Revlimid is a brand-name medication that contains the drug lenalidomide. Lenalidomide is similar to a drug called thalidomide, so Revlimid is called a thalidomide analogue.

Revlimid can be taken by people with the following types of cancer that affect blood cells:

People with multiple myeloma should take Revlimid together with the drug dexamethasone. Revlimid can be given to people with or without a previous auto hematopoietic stem cell transplant (auto-HSCT).

People with myelodysplastic syndromes who have red blood cell transfusion-dependent anemia can take Revlimid alone. People with anemia don't have enough healthy red blood cells. They may need to have a blood transfusion to increase their number of red blood cells.

For people with mantle cell lymphoma, only those who've received two previous treatments can take Revlimid. One of these treatments must have included a drug called bortezomib (Velcade).

For people with follicular and marginal zone lymphomas, only those who've received at least one previous treatment can take Revlimid. For follicular and marginal zone lymphomas, Revlimid should be taken along with the drug rituximab.

Revlimid comes in a capsule that you swallow. It comes in six different strengths: 2.5 milligrams (mg), 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg.

Effectiveness

In a clinical trial, the progression (worsening) of multiple myeloma in people taking Revlimid and dexamethasone was stopped for 25.5 months. In comparison, the progression of multiple myeloma was stopped for 21.2 months in people taking melphalan, prednisone, and thalidomide.

To learn about Revlimid's effectiveness in treating other types of cancer, see the "Revlimid for other uses" section.

Revlimid is available only as a brand-name medication. It's not currently available in generic form.

Revlimid can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Revlimid. These lists don't include all possible side effects.

For more information on the possible side effects of Revlimid, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

More common side effects

The more common side effects of Revlimid can include:

  • cough
  • skin rash or itching
  • diarrhea
  • constipation
  • nausea
  • fatigue (lack of energy)
  • anemia (low levels of red blood cells)
  • insomnia (trouble sleeping)
  • vomiting
  • loss of appetite
  • feeling weak
  • neutropenia or leukopenia (low levels of white blood cells)
  • muscle cramps or spasms
  • upper respiratory infections, such as the common cold
  • infections in your lungs or digestive tract

Most of these side effects may go away within a few days or a couple of weeks. If they're more severe or don't go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Revlimid aren't common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you're having a medical emergency.

Serious side effects and their symptoms can include:

  • Liver failure. Symptoms can include:
    • nausea
    • fatigue
    • diarrhea
    • jaundice (yellowing of your skin and the whites of your eyes)
    • swelling in your legs or belly
  • Tumor lysis syndrome (a serious condition caused by the breakdown of cancer cells). Symptoms can include:
    • tiredness
    • fast or irregular heart rate
    • passing out
    • trouble urinating
    • loose stools
    • muscle weakness or cramps
    • upset stomach, vomiting, or lack of appetite
  • Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Symptoms can include:
    • sores in your mouth
    • a red or purple skin rash that spreads
    • hives
    • blistering or peeling of your skin
  • Tumor flare reaction (an immune system reaction). Symptoms can include:
    • fever
    • rash
    • lymph nodes that feel tender or swollen
    • decreased levels of lymphocytes (a type of white blood cells)
  • Thrombocytopenia (low levels of platelets, a type of blood cell). Symptoms can include:
    • petechiae (a rash with small red or purple dots)
    • purpura (purple, red, or brown bruises)
    • bleeding gums
    • nosebleeds
    • heavy menstrual bleeding
    • blood in your stool or urine

Serious side effects, explained in more detail below in "Side effect details," can include:

Side effect details

You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here's some detail on several of the side effects this drug may or may not cause.

Skin rash

Skin rash can occur in some people taking Revlimid. In clinical studies of people taking Revlimid, skin rash occurred in:

  • 26% of people with multiple myeloma taking Revlimid immediately after diagnosis
  • 32% of people with multiple myeloma taking Revlimid after auto hematopoietic stem cell transplant (auto-HSCT)
  • 21% of people with multiple myeloma taking Revlimid after receiving at least one past treatment
  • 36% of people with myelodysplastic syndromes
  • 22% of people with mantle cell lymphoma
  • 22% of people with follicular and marginal zone lymphomas

For many people, the skin rash is mild and goes away on its own. However, in some people, the rash is severe or doesn't go away. A rash can be a symptom of a more serious side effect from Revlimid.

Tell your doctor if you have a skin rash after taking Revlimid. They can determine if you're having an allergic reaction to Revlimid or if the rash is a symptom of another serious side effect. Your doctor may also adjust your dosage of Revlimid to make sure it's safe for you. They can also recommend ways to soothe your skin rash.

Fatigue

You might experience fatigue (a lack of energy) while taking Revlimid. In most cases, fatigue isn't considered a serious condition.

In clinical studies of Revlimid, fatigue occurred in:

  • 33% of people with multiple myeloma taking Revlimid immediately after diagnosis
  • 23% of people with multiple myeloma taking Revlimid after auto-HSCT
  • 44% of people with multiple myeloma taking Revlimid after receiving at least one past treatment
  • 31% of people of people with myelodysplastic syndromes
  • 34% of people with mantle cell lymphoma
  • 37% of people with follicular and marginal zone lymphomas

If you have fatigue that doesn't go away, talk with your doctor about how to cope with it.

Diarrhea

Revlimid may cause you to have diarrhea for a few days after taking a dose. In clinical studies of people taking Revlimid, diarrhea occurred in:

  • 45% of people with multiple myeloma taking Revlimid immediately after diagnosis
  • 54% of people with multiple myeloma taking Revlimid after auto-HSCT
  • 39% of people with multiple myeloma taking Revlimid after receiving at least one past treatment
  • 49% of people with myelodysplastic syndromes
  • 31% of people with mantle cell lymphoma
  • 32% of people with follicular and marginal zone lymphomas

Symptoms of diarrhea can include:

  • frequent need to empty the bowels
  • fever
  • nausea
  • pain in your abdomen (belly)
  • muscle cramps
  • dehydration (water loss in the body)
  • bloating (belly feels tight or full)
  • large stools
  • blood in your stool

Diarrhea that goes away within a few days and that doesn't affect your daily activities isn't usually considered harmful. However, severe diarrhea can lead to other issues that can be harmful.

Tell your doctor if you have severe diarrhea for more than 2 days. They may prescribe medication to help relieve your symptoms or suggest a nutritional plan to help treat your diarrhea.

Febrile neutropenia

Revlimid can cause neutropenia (low levels of white blood cells). In some cases, neutropenia can lead to febrile neutropenia, which is a rapid rise in body temperature. People with febrile neutropenia have a fever higher than 100°F (38°C) for more than 1 hour.

In clinical studies of people taking Revlimid, febrile neutropenia occurred in:

  • 1% of people with multiple myeloma taking Revlimid immediately after diagnosis
  • 2% to 17% of people with multiple myeloma taking Revlimid after auto-HSCT
  • 2% of people with multiple myeloma taking Revlimid after receiving at least one past treatment with a different drug
  • 5% of people with myelodysplastic syndromes
  • 6% of people with mantle cell lymphoma
  • 2.8% of people with follicular and marginal zone lymphomas

Symptoms of febrile neutropenia can include:

  • fever higher than 100°F (38°C) for more than 1 hour
  • infections in the lung, sinus, ear, gums, or navel (belly button)
  • pain or soreness in your body
  • skin bumps

Febrile neutropenia can be dangerous. High fever can lead to symptoms such as headaches, weakness, and severe infections. In some cases, it can even cause death.

Call your doctor if you have symptoms of febrile neutropenia, especially if you have a fever above 100°F (38°C) for more than 1 hour. Your doctor can prescribe medications to treat your symptoms and help lower your fever.

Deep vein thrombosis

Some people taking Revlimid can get deep vein thrombosis (DVT). This condition occurs when a blood clot forms in your veins. The blood clot doesn't allow blood to move through the vein, so the blood can't reach all your organs and cells.

In clinical studies, only people with certain conditions who were taking Revlimid had DVT. These included:

  • 10% of people with multiple myeloma had DVT when taking Revlimid immediately after diagnosis
  • 7% to 9% of people with multiple myeloma had DVT while taking Revlimid after receiving at least one past treatment with a different drug
  • 4% of people with mantle cell lymphoma had DVT while taking Revlimid
  • 3.4% of people with follicular or marginal zone lymphomas had DVT while taking Revlimid

Symptoms of DVT can include:

  • swelling in your legs or arms
  • muscle cramps
  • deep pain in your legs, ankles, feet, neck, or shoulder
  • changes in your skin (feeling warm, having red or blue coloring, or having pale or dark patches)
  • unexpected pain in your neck or shoulder
  • weakness in your hand

DVT can be very serious. It can cause heart problems that can be life-threatening. Tell your doctor if you're having symptoms of DVT. They can prescribe medication to help relieve your symptoms and treat your DVT. Call 911 if your symptoms feel life-threatening or if you think you're having a medical emergency.

Pulmonary embolism

Revlimid may cause a pulmonary embolism. Pulmonary embolism occurs when a blood clot forms in the arteries of your lungs. The blood clot blocks your arteries and doesn't allow blood to move through them.

In clinical studies of people taking Revlimid, pulmonary embolism occurred in:

  • 4% of people with multiple myeloma taking Revlimid after trying other medications that were not effective
  • 2% of people with myelodysplastic syndromes
  • 2% of people with mantle cell lymphoma
  • 2.3% of people with follicular and marginal zone lymphomas

Symptoms of pulmonary embolism can include:

  • shortness of breath
  • weak pulse
  • irregular or rapid heartbeat
  • clammy or bluish skin
  • feeling lightheaded
  • feeling anxious or not being able to relax
  • intense pain in your chest
  • fainting
  • spitting up blood

Pulmonary embolism can lead to death if untreated. Tell your doctor right away if you're having symptoms of pulmonary embolism. They can prescribe medication to help relieve your symptoms and treat your pulmonary embolism. Call 911 if your symptoms feel life-threatening or if you think you're having a medical emergency.

Heart problems

Revlimid can cause heart problems such as atrial fibrillation (irregular heartbeat). These problems are more common in people taking Revlimid to treat multiple myeloma.

In clinical studies, 7% of people with multiple myeloma taking Revlimid for the first time had atrial fibrillation. In this same group, 1.4% of people with multiple myeloma taking Revlimid had heart attacks.

Atrial fibrillation occurred in 4% of people with multiple myeloma taking Revlimid after receiving at least one past treatment with a different drug. In this same group, 1.7% of people taking Revlimid had heart attacks.

Less than 5% of people with multiple myeloma taking Revlimid for myelodysplastic syndromes had atrial fibrillation or heart attacks.

Symptoms of heart problems can include:

  • fatigue (lack of energy)
  • feeling weak
  • feeling dizzy or lightheaded
  • fainting
  • not feeling strong enough to exercise as usual
  • shortness of breath
  • confusion
  • bluish skin color, especially on the lips, gums, fingertips, or around the eyes
  • heart palpitations (feeling of skipped or extra heartbeats)
  • intense pain in your chest

Heart problems can be very serious and even fatal (cause death). Call your doctor right away if you have any of the symptoms listed above. They can prescribe medication to help relieve your symptoms and treat your heart problems. But if your symptoms feel life-threatening or you think you're having a medical emergency, call 911 or go to the nearest emergency room.

Stroke

Revlimid may cause a stroke in some people taking Revlimid for multiple myeloma. A stroke occurs when your blood can't reach your brain. This means your brain doesn't receive enough oxygen, and brain cells start to die. A stroke can be life-threatening if not treated immediately.

In clinical studies, about 2% of people with multiple myeloma taking Revlimid after trying other medications that were not effective had a stroke. Stroke wasn't a side effect for people who took Revlimid to treat other conditions.

Symptoms of a stroke can include:

  • intense headache, vomiting, and nausea
  • dizziness
  • trouble walking, losing your balance, or lack of coordination
  • vision problems (darker or blurred vision)
  • trouble speaking or understanding others
  • numbness or not being able to move parts of your legs, arms, or face (especially on one side of the body)

Call 911 or go to the nearest emergency room right away if you think you're having a stroke.

Other cancers

In clinical trials, several studies showed that some people who took Revlimid developed other cancers. These cancers included acute myeloid leukemia and myelodysplastic syndrome.

One study looked at people with multiple myeloma who took Revlimid after auto-HSCT. In these people, other cancers occurred in:

  • 14.9% of people taking Revlimid alone
  • 8.8% of people taking a placebo (a treatment with no active drug)

If you're concerned about your cancer risk while taking Revlimid, talk with your doctor.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Revlimid. Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have a severe allergic reaction to Revlimid. Call 911 if your symptoms feel life-threatening or if you think you're having a medical emergency.

Hair loss (not a side effect)

Revlimid should not cause hair loss. However, hair loss could be a side effect of other medications you may be taking to treat your cancer.

Talk with your doctor if you're concerned about hair loss from your cancer treatments.

The Food and Drug Administration (FDA) approves prescription drugs such as Revlimid to treat certain conditions. Revlimid is FDA-approved to treat multiple myeloma in people with or without a previous auto hematopoietic stem cell transplant (auto-HSCT).

Multiple myeloma is a type of cancer that affects your blood cells. In some cases, people with this cancer may need to get a transplantation of cells to generate new blood cells. When the cells come from a person's own body, this transplantation is called auto-HSCT.

If you have multiple myeloma, you should take Revlimid along with dexamethasone. This drug combination is recommended in the clinical guidelines for multiple myeloma.

Effectiveness

A clinical study evaluated the use of Revlimid with dexamethasone to treat multiple myeloma. In this study, 535 people with multiple myeloma took Revlimid. Also, 547 people with multiple myeloma took the drugs melphalan, prednisone, and thalidomide (MPT). This study looked at people who were newly diagnosed with multiple myeloma.

The results of the study showed that Revlimid plus dexamethasone was effective in treating multiple myeloma. People taking this combination of drugs lived about 58.9 months after starting treatment. In comparison, people taking MPT lived about 48.5 months after starting treatment.

Also, the progression (worsening) of multiple myeloma was stopped for about 25.5 months in people taking Revlimid plus dexamethasone. In comparison, the progression of multiple myeloma was stopped for about 21.2 months in people taking MPT.

Revlimid's effectiveness was also shown in people with a previous auto-HSCT. In a clinical study, people with an auto-HSCT taking Revlimid plus dexamethasone lived about 111 months after starting treatment. In comparison, people who took a placebo (a drug with no active treatment) lived about 84.2 months after starting treatment.

This study also looked at the progression of multiple myeloma. Revlimid slowed down cancer progression by 62% compared to a placebo.

Two clinical studies evaluated the use of Revlimid in people with multiple myeloma who had received at least one past treatment. In these studies, Revlimid plus dexamethasone was compared to a placebo plus dexamethasone. Revlimid slowed down cancer progression by 68% to 72% compared to a placebo.

In addition to multiple myeloma, the Food and Drug Administration (FDA) has approved Revlimid to treat other conditions. Revlimid may also be used off-label for other conditions. Off-label use is when a drug that's approved to treat one condition is used to treat a different condition.

Revlimid for myelodysplastic syndromes

Revlimid is FDA-approved to treat people with myelodysplastic syndromes (a type of cancer in your blood). However, Revlimid should only be used by people who also have red blood cell (RBC) transfusion-dependent anemia. People with anemia don't have enough red blood cells.

A clinical study analyzed how well Revlimid works in people who have myelodysplastic syndromes. In the study, 148 people with this cancer took Revlimid. The trial identified how many people needed RBC transfusions after taking Revlimid. After the trial, 67% of people who took Revlimid did not need RBC transfusions.

Revlimid for mantle cell lymphoma

Revlimid is FDA-approved (and recommended by clinical guidelines) to treat mantle cell lymphoma in people who've received two previous treatments for this condition. Mantle cell lymphoma is a type of cancer that affects your B cells.

If you're going to take Revlimid, one of those previous treatments needs to have included the chemotherapy drug bortezomib (Velcade).

In clinical studies, the use of Revlimid with rituximab was analyzed in 134 people with mantle cell lymphoma. All of the people had been previously treated with two or more other therapies, including bortezomib.

By the end of the trial, 26% of people taking Revlimid showed a positive response to the medications. Of people who had a positive response to Revlimid, half lived for 16.6 months or longer without cancer progression (worsening).

Revlimid for follicular lymphoma or marginal zone lymphoma

Revlimid is recommended in clinical guidelines and is FDA-approved to treat follicular lymphoma. Follicular lymphoma is a cancer that affects the B cells in your blood. Only people who've received one past treatment for follicular lymphoma should take Revlimid. Revlimid is approved to be taken with the drug rituximab for follicular lymphoma.

Revlimid is also FDA-approved and recommended in clinical guidelines to treat people with marginal zone lymphoma. Marginal zone lymphoma is a type of blood cancer that affects the B cells of your blood.

People with marginal zone lymphoma should only take Revlimid if they've received previous treatment for the condition. Revlimid is approved to be taken with rituximab for marginal zone lymphoma.

Effectiveness

Clinical studies evaluated the use of Revlimid with rituximab in people with follicular lymphoma or marginal zone lymphoma.

In one study, 358 people with follicular lymphoma or marginal zone lymphoma who had previously been treated with another medication participated. Revlimid and rituximab were taken by 178 people, and 180 people took rituximab alone.

At the end of the study, 77.5% of the people taking Revlimid with rituximab responded well to these medications. The progression of their cancer was stopped for about 39.4 months. In comparison, 53.3% of people who took rituximab alone responded well to this treatment. The progression of their cancer was stopped for about 14.1 months.

Off-label uses for Revlimid

In addition to the uses listed above, Revlimid may be used off-label for other uses. Off-label drug use is when a drug that's approved for one use is used for a different one that's not approved.

Revlimid for Hodgkin lymphoma

Revlimid isn't FDA-approved to treat Hodgkin lymphoma (a type of cancer that affects a certain kind of white blood cell). However, clinical guidelines recommend Revlimid for people who've taken other medications to treat Hodgkin lymphoma but still have the condition.

Talk with your doctor if you have Hodgkin lymphoma and want to take Revlimid. They can help determine if Revlimid is a good option for you.

Revlimid for systemic light-chain amyloidosis

Revlimid isn't FDA-approved to treat systemic light-chain amyloidosis, but clinical guidelines recommend its use for this condition. Systemic light-chain amyloidosis is a disease that affects your body's ability to produce proteins that fight infections.

In this disease, Revlimid should be taken with dexamethasone or with dexamethasone and cyclophosphamide.

Tell your doctor if you have systemic light-chain amyloidosis and want to take Revlimid. They can help determine if Revlimid is a good option for you.

Revlimid can be taken alone, or it can be used with other drugs. Whether you take Revlimid alone or with other drugs will depend on the condition you're using it to treat:

  • For myelodysplastic syndrome and mantle cell lymphoma, you'll likely take Revlimid alone.
  • For multiple myeloma, you'll likely take Revlimid with the drug dexamethasone.
  • For multiple myeloma after auto hematopoietic stem cell transplant (auto-HSCT), you'll likely take Revlimid alone.
  • For follicular and marginal zone lymphomas, you'll likely take Revlimid with the drug rituximab.

Dexamethasone and rituximab each help make Revlimid more effective. If you need to take one of these drugs with Revlimid, your doctor can determine how much you should take.

The Revlimid dosage your doctor prescribes will depend on several factors. These include:

  • the type and severity of the condition you're using Revlimid to treat
  • other medical conditions you may have

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Revlimid comes as a capsule that you take by mouth. You should swallow the capsule with a glass of water.

Revlimid capsules come in six strengths: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg.

Dosing cycles

For most conditions, your doctor will set a dosing cycle for you to follow while taking Revlimid. A cycle lasts a certain number of days. Your dosing cycle will tell you which days to take Revlimid and which days you shouldn't take a dose. Your cycle will be determined by the type of cancer you're using Revlimid to treat.

Dosage for multiple myeloma

If you have multiple myeloma and haven't had an auto hematopoietic stem cell transplant (auto-HSCT), you'll start out taking 25 mg of Revlimid daily. You'll take this dose on days 1 to 21 of a 28-day cycle (see "Dosing cycles" above). You shouldn't take Revlimid on days 22 to 28 of the cycle.

If you have multiple myeloma and have had an auto-HSCT, you'll start out taking 10 mg of Revlimid daily. You'll take this dose every day during the 28-day cycle. In this case, there won't be any days in the cycle when you don't take Revlimid.

Once the cycle ends, you will start a new cycle. Your doctor will tell you how many cycles you should complete. This may depend on how your body reacts to Revlimid. After three cycles, your doctor may increase your dose of Revlimid.

Dosage for myelodysplastic syndromes

If you have myelodysplastic syndromes and red blood cell transfusion-dependent anemia, you should take 10 mg of Revlimid daily. There are no dosing cycles for this condition. Your doctor will monitor how your body reacts to Revlimid. Based on this, they'll indicate when you should stop taking Revlimid.

Dosage for mantle cell lymphoma

If you have mantle cell lymphoma, you should take 25 mg of Revlimid daily. You'll take Revlimid on days 1 to 21 of a 28-day cycle (see "Dosing cycles" above). You won't take Revlimid on days 22 to 28 of your cycle.

Dosage for follicular or marginal zone lymphoma

If you have follicular and marginal zone lymphoma, you should take 20 mg of Revlimid daily. You'll take Revlimid on days 1 to 21 of a 28-day cycle (see "Dosing cycles" above). You won't take Revlimid on days 22 to 28 of the cycle.

Your doctor will determine how many cycles you should complete, based on your condition. Most likely, you won't take Revlimid for more than 12 cycles.

What if I miss a dose?

If you notice you missed a dose and it's within 12 hours of when you should've taken it, take the dose immediately. However, don't take the dose if it's 12 hours or more after when you should've taken it. In this case, you should skip that dose of Revlimid.

To help make sure that you don't miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Will I need to use this drug long term?

Revlimid is meant to be used as a long-term treatment. If you and your doctor determine that Revlimid is safe and effective for you, you'll likely take it long term.

There is no known interaction between Revlimid and alcohol. However, alcohol could interact with other drugs you may be taking to treat your condition.

If you drink alcohol, talk with your doctor to make sure it's safe to drink alcohol with the medications you're taking.

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you're interested in finding an alternative to Revlimid, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label use is when a drug that's approved to treat one condition is used to treat a different condition.

Alternatives for multiple myeloma

Examples of other drugs that may be used to treat multiple myeloma include:

  • bortezomib (Velcade)
  • carfilzomib (Kyprolis)
  • ixazomib (Ninlaro)
  • daratumumab (Darzalex)
  • elotuzumab (Empliciti)
  • bendamustine (Belrapzo, Bendeka, Treanda)*
  • thalidomide (Thalomid)

Alternatives for myelodysplastic syndromes

Examples of other drugs that may be used to treat myelodysplastic syndromes include:

  • azacitidine (Vidaza)
  • decitabine (Dacogen)
  • imatinib (Gleevec)

Alternatives for mantle cell lymphoma

Examples of other drugs that may be used to treat mantle cell lymphoma include:

  • bortezomib (Velcade)
  • bendamustine (Belrapzo, Bendeka, Treanda)*
  • acalabrutinib (Calquence)
  • ibrutinib (Imbruvica)
  • venetoclax (Venclexta)*
  • rituximab (Rituxan)*

Alternatives for follicular lymphoma

Examples of other drugs that may be used to treat follicular lymphoma include:

  • rituximab (Rituxan)
  • obinutuzumab (Gazyva)
  • bendamustine (Belrapzo, Bendeka, Treanda)*
  • ibritumomab (Zevalin)
  • copanlisib (Aliqopa)
  • duvelisib (Copiktra)
  • idelalisib (Zydelig)

Alternatives for marginal zone lymphoma

Examples of other drugs that may be used to treat marginal zone lymphoma include:

  • ibrutinib (Imbruvica)
  • bendamustine (Belrapzo, Bendeka, Treanda)*
  • ibritumomab (Zevalin)*
  • rituximab (Rituxan)*
  • copanlisib (Aliqopa)*
  • duvelisib (Copiktra)*
  • idelalisib (Zydelig)*

* Used off-label for this condition

You may wonder how Revlimid compares to other medications that are prescribed for similar uses. Here we look at how Revlimid and Velcade are alike and different.

Uses

Revlimid is used to treat certain types of cancer, including:

  • multiple myeloma
  • myelodysplastic syndromes
  • mantle cell lymphoma
  • follicular lymphoma
  • marginal zone lymphoma

Velcade is used to treat multiple myeloma and mantle cell lymphoma.

Revlimid contains the drug lenalidomide. Velcade contains the drug bortezomib.

Revlimid and Velcade belong to different classes of medications, so the way they work in your body is different.

Drug forms and administration

Revlimid comes as a capsule you take by mouth. It comes in six strengths: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg.

Velcade comes as powder that's mixed with liquid to form a solution. It's given as a subcutaneous injection (under the skin) or an intravenous injection (into a vein). Velcade comes in one strength of 3.5 mg.

Side effects and risks

Revlimid and Velcade have some similar side effects and others that differ. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Revlimid, with Velcade, or with both drugs (when taken individually).

  • Can occur with Revlimid:
    • cough
    • muscle cramps or spasms
    • insomnia (trouble sleeping)
  • Can occur with Velcade:
    • neuralgia (nerve pain)
  • Can occur with both Revlimid and Velcade:
    • nausea
    • diarrhea
    • constipation
    • skin rash or itching
    • anemia (low levels of red blood cells)
    • upper respiratory infections, such as the common cold
    • infections in your lungs or digestive tract
    • neutropenia or leukopenia (low levels of white blood cells)
    • fatigue (lack of energy)
    • vomiting
    • loss of appetite
    • feeling weak

Serious side effects

These lists contain examples of serious side effects that can occur with Revlimid, with Velcade, or with both drugs (when taken individually).

Effectiveness

These drugs haven't been directly compared in clinical studies, but studies have found both Revlimid and Velcade to be effective for treating multiple myeloma and mantle cell lymphoma.

Costs

Revlimid and Velcade are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

According to estimates on WellRx.com, Revlimid generally costs more than Velcade. The actual price you'll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Revlimid and bendamustine are prescribed for similar uses. Below are details of how these medications are alike and different.

Uses

Revlimid is approved by the Food and Drug Administration (FDA) to treat multiple myeloma. It's also FDA-approved to treat mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma.

As well, Revlimid is FDA-approved to treat myelodysplastic syndromes in people who have red blood cell transfusion-dependent anemia.

Bendamustine is approved to treat follicular lymphoma and marginal zone lymphoma. It's also approved to treat chronic lymphocytic leukemia (a type of cancer that affects the B cells in your blood).

Bendamustine is used off-label (a nonapproved use) to treat multiple myeloma and mantle cell lymphoma.

Revlimid contains the drug lenalidomide. Bendamustine is the generic form of several brand-name drugs, including Treanda, Belrapzo, and Bendeka. Revlimid and bendamustine belong to different classes of medications, so the way they work in your body is different.

Drug forms and administration

Revlimid comes as a capsule you take by mouth. There are six different strengths: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg.

Bendamustine is given as an intravenous injection (injection into your veins). It comes in two forms with different strengths:

  • a solution available in one strength: 100 milligrams per 4 milliliters (25 mg/mL)
  • a powder (that is dissolved in water) available in two strengths: 25 mg and 100 mg

Side effects and risks

Revlimid and bendamustine are both used to treat cancer. Therefore, these medications can cause similar side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Revlimid, with bendamustine, or with both drugs (when taken individually).

  • Can occur with Revlimid:
  • Can occur with bendamustine:
    • fever
    • weight loss
    • stomatitis (inflamed and sore mouth)
    • lymphopenia (low levels of white blood cells)
  • Can occur with both Revlimid and bendamustine:
    • nausea
    • diarrhea
    • fatigue (lack of energy)
    • constipation
    • cough
    • skin rash or itching
    • vomiting
    • loss of appetite
    • neutropenia or leukopenia (low levels of white blood cells)
    • anemia (low levels of red blood cells)

Serious side effects

These lists contain examples of serious side effects that can occur with Revlimid, with bendamustine, or with both drugs (when taken individually).

  • Can occur with Revlimid:
  • Can occur with bendamustine:
  • Can occur with both Revlimid and bendamustine:
    • allergic reaction
    • febrile neutropenia (high fever along with low levels of white blood cells)
    • heart problems
    • severe rash
    • thrombocytopenia (low levels of platelets, a type of blood cell)

Effectiveness

The use of Revlimid and bendamustine in treating follicular lymphoma has been directly compared in a clinical study.

In this study, 11 people took bendamustine with rituximab and 12 people took Revlimid with rituximab. All people in the study had follicular lymphoma and were receiving treatment for the first time.

The study showed that lenalidomide plus rituximab was effective in treating follicular lymphoma. But the combination of bendamustine plus rituximab was even more effective.

About 64% of people who took bendamustine plus rituximab had a positive response to treatment. In comparison, about 17% of people who took lenalidomide plus rituximab had a positive response.

Also, bendamustine with rituximab caused fewer side effects than lenalidomide with rituximab.

Costs

Revlimid and bendamustine are both available as brand-name drugs only. The brand names for bendamustine are Bendeka, Treanda, and Belrapzo. There are currently no generic forms of either drug.

According to estimates on WellRx.com, Revlimid generally costs more than bendamustine. The actual price you'll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Revlimid can interact with other medications. Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

Revlimid and other medications

Below is a list of medications that can interact with Revlimid. This list does not contain all drugs that may interact with Revlimid.

Before taking Revlimid, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Revlimid and digoxin

Digoxin is used to treat different types of cardiovascular problems, including problems with your heartbeat. Revlimid can increase the amount of digoxin that's in your blood. High amounts of digoxin can raise your risk of having side effects.

Tell your doctor if you're taking digoxin while using Revlimid. They can do blood tests periodically to monitor the amount of digoxin in your blood. This can help make sure the combination of digoxin and Revlimid is safe for you.

Revlimid and drugs that may increase the risk of thrombosis

Revlimid can raise your risk of thrombosis (a blood clot). Blood clots are masses that form within your veins and arteries. They don't allow your blood to move freely through your veins and arteries, which can cause serious issues.

Other medications, including erythropoietic drugs and estrogen-based medications, can also increase your risk of having thrombosis. Erythropoietic drugs are used to increase your number of blood cells. Estrogen-based medications can be used to prevent pregnancy or treat symptoms of menopause. Taking these drugs with Revlimid can raise your risk of thrombosis even more.

Tell your doctor about all medications you're taking. They can check if those medications can also raise your risk of thrombosis. Based on this, they may prescribe medication to help prevent thrombosis.

Revlimid and herbs and supplements

There aren't any herbs or supplements that have been specifically reported to interact with Revlimid. However, you should still check with your doctor or pharmacist before using any of these products while taking Revlimid.

Here are answers to some frequently asked questions about Revlimid.

Can I take Revlimid if I'm going to have surgery?

Yes, you can. However, Revlimid may raise your risk of getting infections after the surgery. If you need to have surgery, tell your doctor that you're taking Revlimid. They can prescribe antibiotics to help lower your risk of getting infections after surgery.

If I have leukemia, can I take Revlimid for treatment?

No. Revlimid hasn't been approved for the treatment of leukemia. It's only approved for the treatment of multiple myeloma, myelodysplastic syndromes, and certain lymphomas such as mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma.

If you have leukemia, talk with your doctor about your treatment options.

Can Revlimid cause other cancers to occur?

It's possible. In clinical studies, people who took Revlimid had a higher risk of developing new cancers. This included leukemia, myelodysplastic syndromes, and skin cancer.

Talk to your doctor about your risk of developing new cancers if you take Revlimid. Other factors can increase your risk of developing new cancers, such as genetics and using tobacco. Your doctor will check for new symptoms of cancer during your treatment.

Can I take Revlimid while pregnant?

No, pregnant women should not take Revlimid. It can cause miscarriages and severe birth defects.

Talk with your doctor about treating your cancer if you are pregnant or planning to become pregnant. They can discuss safe treatment options with you.

Note: For more information, see the "Revlimid and pregnancy" section.

Do I have to register for the Revlimid REMS program?

Yes. Revlimid is only prescribed to people who enroll in the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program. This program's purpose is to help prevent serious risks to fetuses and to help prevent birth defects. People who enroll in the Revlimid REMS program must meet certain requirements before they can be prescribed Revlimid.

Talk with your doctor if you have any questions about joining the Revlimid REMS program.

Note: For more information on Revlimid side effects during pregnancy, see the "Revlimid and pregnancy" section.

Can I buy Revlimid in any pharmacy?

No, only pharmacies enrolled in the Revlimid REMS program can dispense Revlimid. Ask your doctor if you aren't sure where you can get Revlimid. They can help find a pharmacy near you that dispenses Revlimid. (See the question above to learn more about the Revlimid REMS program.)

Do I need prior authorization to get Revlimid?

Probably. Many health insurers require prior authorization (preapproval) before agreeing to cover Revlimid. Your doctor must request prior authorization on your behalf. Once your insurance company approves coverage for Revlimid, your doctor will let you know when you can start taking it.

Women should avoid getting pregnant 4 weeks before taking Revlimid, while taking Revlimid, and 4 weeks after they stop taking Revlimid. This is because Revlimid is very similar to the drug thalidomide, which is known to cause miscarriages and severe birth defects.

In animal studies, the use of Revlimid in pregnant animals caused miscarriages and severe birth defects. This information, along with the known side effects of thalidomide, suggest that Revlimid may cause serious problems if used during pregnancy.

Before taking Revlimid, you must enroll in the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program. This program's purpose is to help prevent serious risks to fetuses and to help prevent birth defects. For more information, visit the program website or call 888-423-5436.

Pregnancy tests

If you can get pregnant, your doctor will check that you aren't pregnant when you start taking Revlimid. They will ask you to take a pregnancy test 10 to 14 days before you start taking Revlimid. Then they may have you take one more test the day before your first dose of Revlimid.

Once you start taking Revlimid, your doctor will have you routinely take pregnancy tests. You will take tests every week at the beginning of your treatment. Then you will take tests every 2 to 4 weeks.

Revlimid may cause miscarriages and severe birth defects if taken during pregnancy. If you're sexually active and you or your partner can become pregnant, pregnancy should be avoided while either partner is taking Revlimid.

You should begin using at least two methods of birth control 4 weeks before you start taking Revlimid. Continue using two methods while taking Revlimid through 4 weeks after you've stopped taking it.

It's important to note that Revlimid is present in the sperm of men taking it. Therefore, men with female sexual partners who could become pregnant should always use a condom during sexual activity in the time frame mentioned above. This even applies to men who've had vasectomies. Also, men taking Revlimid should not donate sperm.

Note: See the "Revlimid and pregnancy" section above for more information on Revlimid and pregnancy.

There aren't clinical studies that look at Revlimid use while breastfeeding. But many drugs do pass through breast milk. If Revlimid also passes through breast milk, it could harm your child.

If you're taking Revlimid and plan to breastfeed, talk with your doctor about the possible risks and benefits.

As with all medications, the cost of Revlimid can vary. To find current prices for Revlimid in your area, check out WellRx.com.

The cost you find on WellRx.com is what you may pay without insurance. The actual price you'll pay depends on your insurance plan, your location, and the pharmacy you use.

Financial and insurance assistance

If you need financial support to pay for Revlimid, or if you need help understanding your insurance coverage, help is available.

Celgene, the manufacturer of Revlimid, offers a program called Celgene Patient Support. For more information and to find out if you're eligible for support, call 800-931-8691 or visit the program website.

You should take Revlimid according to your doctor or healthcare provider's instructions.

When to take

Your doctor will set a dosing cycle for you to follow while taking Revlimid. A cycle lasts a certain number of days. Your dosing cycle will tell you which days to take Revlimid and which days you shouldn't take a dose. Your cycle will be determined by the type of cancer you're using Revlimid to treat.

After the last day of your cycle finishes, you'll start a new, identical cycle. Your doctor will monitor how your cancer develops while you take Revlimid. Based on this, they'll determine how many cycles of Revlimid you should complete.

To learn about dosage cycles for your condition, see the "Revlimid dosage" section.

Taking Revlimid with food

It doesn't matter if you take Revlimid with or without food.

Can Revlimid capsules be opened?

No, you shouldn't open or break a Revlimid capsule. You should swallow the entire capsule with water.

If a Revlimid capsule breaks, try not to touch the powder that was inside the capsule. If you accidentally come into contact with the powder, wash your hands immediately with soap and water.

Tell your doctor if you have trouble swallowing the Revlimid capsule. They can give you some advice on how to take Revlimid. If you still have trouble taking it, talk with your doctor about other medications that may be easier to take.

Revlimid is approved to treat the following types of cancer in your blood cells:

What is cancer?

Cancer is a condition that involves your cells multiplying uncontrollably.

Cancer can affect the way your cells and organs work. As a result, you may start having symptoms of cancer such as bleeding, changes in appetite, pain, and headaches.

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects your blood cells. In particular, it affects your white blood cells and plasma cells.

In people with multiple myeloma, white blood cells and plasma cells grow and multiply very quickly and uncontrollably. This causes cancer in the blood. As the cancer cells move through your blood, they reach all parts of your body. Some cancer cells may build up in certain organs and cause organ-specific symptoms.

What is myelodysplastic syndrome?

Myelodysplastic syndrome is a type of cancer in the blood. Some people with myelodysplastic syndrome also have anemia (low levels of red blood cells). Red blood cells are important because they carry oxygen through your blood to the rest of your body.

People with red blood cell transfusion-dependent anemia may need to have a red blood cell transfusion, a procedure in which they receive donated blood.

What are lymphomas?

Lymphoma is cancer that affects specific cells (called white blood cells) within your blood, called lymphocytes. The cancerous lymphocytes grow and multiply uncontrollably. They move through your blood and reach several parts of your body.

There are different types of lymphoma, but most of them share many characteristics. Types of lymphoma include:

  • mantle cell lymphoma
  • follicular lymphoma
  • marginal zone lymphoma

What does Revlimid do?

Revlimid can stop cancer cells from multiplying, which stops the progression (worsening) of cancer. Revlimid can also cause existing cancer cells to die.

In certain types of cancers, Revlimid's effects can be increased if it's taken with other drugs. Examples of drugs that increase Revlimid's effects include:

  • dexamethasone, for people with multiple myeloma
  • rituximab, in people with follicular and marginal zone lymphomas

How long does it take to work?

Revlimid will likely start working in your body a few hours after you start taking it. However, you may not notice any change in your symptoms. Your doctor will determine how well Revlimid is working for you based on the results of your blood tests.

If you have questions about Revlimid's effects on your condition, talk with your doctor.

This drug comes with several precautions.

FDA warnings

This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

Severe pregnancy harm

Revlimid isn't recommended for pregnant women. This is because Revlimid contains the drug lenalidomide, which is very similar to the drug thalidomide. In pregnant women, thalidomide can cause severe birth defects or miscarriage.

Women taking Revlimid should avoid becoming pregnant while taking this medication. Once women stop taking Revlimid, they should wait at least 4 weeks before becoming pregnant.

Before being prescribed Revlimid, you must enroll in the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program. This program's purpose is to help prevent miscarriages and birth defects. People who enroll in the Revlimid REMS program must meet certain requirements before they can be prescribed Revlimid.

Severe decrease in blood cell levels

Revlimid can cause neutropenia (low levels of white blood cells). It can also cause thrombocytopenia (low levels of platelets, another type of blood cell). These conditions can raise your risk of getting infections. These conditions may also make you bruise or bleed more easily.

If you're receiving treatment for certain types of myelodysplastic syndromes, you should have your complete blood counts monitored weekly for the first 8 weeks of treatment and at least monthly after that. You may have to temporarily stop your dosage of Revlimid or lower your dose. You may need blood product support or growth factors.

Dangerous blood clots

Venous thromboembolism is a blood clot in a vein. Arterial thromboembolism is a blood clot in an artery.

Deep vein thrombosis (DVT) and pulmonary embolism are types of venous thromboembolism. Taking Revlimid can significantly raise your risk of developing DVT and pulmonary embolism. Also, if you take Revlimid along with dexamethasone for multiple myeloma, arterial thromboembolism can lead to heart attack and stroke.

Symptoms of DVT and pulmonary embolism include shortness of breath, chest pain, and arm or leg swelling.Call your doctor right away if you get any of these symptoms. Call 911 if your symptoms feel life-threatening or if you think you're having a medical emergency.

Other precautions

Before taking Revlimid, talk with your doctor about your health history. Revlimid may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Chronic lymphocytic leukemia. You shouldn't take Revlimid if you have chronic lymphocytic leukemia (CLL). If you have CLL, taking Revlimid may raise your risk of death.
  • Treatment with pembrolizumab (Keytruda). You shouldn't take Revlimid or drugs similar to it (such as thalidomide) if you take pembrolizumab to treat tumors. Taking Revlimid with pembrolizumab may raise your risk of death because of how these drugs interact.
  • Cutaneous reactions to thalidomide. If you've had a severe cutaneous reaction (skin rash) to thalidomide in the past, you shouldn't take Revlimid. Thalidomide and Revlimid are very similar drugs, so you could also have a life-threatening cutaneous reaction to Revlimid.

Using more than the recommended dosage of Revlimid can lead to serious side effects.

Overdose symptoms

Symptoms of an overdose can include:

  • itchy skin
  • hives
  • skin rash
  • increased liver proteins
  • neutropenia (low levels of white blood cells)
  • thrombocytopenia (low levels of platelets, a type of blood cell)

What to do in case of overdose

If you think you've taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

When you get Revlimid from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee the medication will be effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Revlimid capsules should be stored at room temperature, 68°F to 77°F (20°C to 25°C). If you're traveling, Revlimid may be stored at temperatures of 59°F to 86°F (15°C to 30°C).

Revlimid capsules should be kept in a tightly sealed container. Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.

Disposal

If you no longer need to take Revlimid and have leftover medication, it's important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

Make sure you don't open or break the capsules while disposing of them.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

The following information is provided for clinicians and other healthcare professionals.

Indications

Revlimid is indicated for the treatment of multiple myeloma in adults in combination with dexamethasone. Revlimid can also be used as monotherapy for multiple myeloma in adult patients who've had an auto hematopoietic stem cell transplant (auto-HSCT) and need maintenance treatment.

Revlimid is also indicated for the treatment of people with red blood cell transfusion-dependent anemia due to low- or intermediate-risk myelodysplastic syndromes. Revlimid should be used for people with a deletion 5q cytogenetic abnormality.

Also, Revlimid can be used to treat certain lymphomas. Below is a list of the lymphomas for which Revlimid has been indicated:

  • Mantle cell lymphoma: Revlimid indication is limited to patients who received at least two prior therapies, including bortezomib, but presented disease relapses or progressions.
  • Follicular lymphoma: Revlimid indication is only in combination with rituximab.
  • Marginal zone lymphoma: The use of Revlimid is only as a combination therapy with rituximab.

Mechanism of action

Revlimid is classified as a thalidomide analogue. It acts by targeting the enzymatic complex called E3 ubiquitin ligase. Its binding is through the protein cereblon, which is present in the cullin ring of the complex.

Revlimid inhibits proliferation and induces apoptosis of hematopoietic cancer cells. The cells targeted by Revlimid are present in multiple myeloma, myelodysplastic syndromes, and mantle cell, follicular, and marginal zone lymphomas.

Additional in vivo effects have been observed with Revlimid. In models of hematopoietic tumors, Revlimid delays the growth of some tumors.

Revlimid also has immunomodulatory effects. It acts on T-lymphocytes and natural killer cells and increases their proliferation and activation. This augments the levels of interleukin-2 and interferon-gamma, causing antibody-dependent cell-mediated cytotoxicity (ADCC). It also reduces the levels of pro-inflammatory cytokines secreted by monocytes.

Pharmacokinetics and metabolism

Revlimid is rapidly absorbed when taken orally. Peak concentrations are reached 0.5 to 6 hours following its administration. Both the peak concentration and area under the curve (AUC) show linear pharmacokinetics with increases in the dose. Revlimid has an elimination half-life of 3 to 5 hours.

In healthy individuals taking 25 mg of Revlimid, a high-fat meal decreased the AUC and peak concentration by 20% and 50%, respectively. However, Revlimid can be administered without regard to meals.

Thirty percent of Revlimid binds to plasma proteins.

The majority of Revlimid (approximately 95%) doesn't undergo metabolic transformation. The remainder is metabolized to 5­hydroxy­lenalidomide and N­acetyl­lenalidomide.

Contraindications

Pregnancy

The use of Revlimid is contraindicated in pregnancy. This is because Revlimid can lead to embryo-fetal death and severe birth defects.

Pregnant women should be advised about the dangerous consequences of taking Revlimid during pregnancy.

Note: For more information on Revlimid effects in pregnancy, see the "Revlimid and pregnancy" section above.

Severe hypersensitivity reactions

The use of Revlimid is contraindicated in patients with severe hypersensitivity reactions, including:

  • angioedema
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis

Revlimid should be discontinued immediately if severe hypersensitivity reactions occur. Otherwise, it can lead to anaphylactic shock and death.

Note: For more information on hypersensitivity reactions, see the "Revlimid precautions" section above.

Storage

The storage temperature range should be 68°F to 77°F (20°C to 25°C). In some cases, the temperature range can vary from 59°F to 86°F (15°C to 30°C).

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.