Onivyde (irinotecan liposome)

Onivyde generic

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

A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics usually cost less than brand-name drugs.

Onivyde dosage

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

• whether your cancer has already been treated
• your body surface area (BSA) in square meters (m²), which is an estimate of body size
• genetic (inherited) factors that affect how well your body breaks down Onivyde
• side effects you may have

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

Drug forms and strengths

Onivyde comes as a solution. It comes in a single-use vial that contains 43 milligrams (mg) of Onivyde per 10 milliliters (mL) of solution.

A healthcare professional will give you Onivyde as an intravenous (IV) infusion. An IV infusion is an injection into a vein that’s given over a period of time. Each infusion is typically given over 90 minutes.

You’ll usually receive Onivyde in an infusion center. To learn more about what to expect when receiving Onivyde, talk with your doctor or visit the drug manufacturer’s website.

Dosage for metastatic pancreatic cancer

Onivyde is approved to treat metastatic* pancreatic cancer in specific situations. For this purpose, Onivyde is given with certain other chemotherapy drugs.

When prescribed with fluorouracil, leucovorin, and oxaliplatin: The usual dosage of Onivyde is 50 mg/m² every 2 weeks. For example, if your doctor calculates your BSA as being 1.6 m², you’ll receive 80 mg of the drug per infusion.

When prescribed with fluorouracil and leucovorin: The usual dosage of Onivyde is 70 mg/m² every 2 weeks. For example, if your doctor calculates your BSA as being 1.6 m², you’ll receive 112 mg of the drug per infusion.

Your doctor may prescribe a different dosage based on genetic factors that affect how well your body breaks down Onivyde. If you have questions about the dosage that’s right for you, talk with your doctor.

* “Metastatic” means the cancer has spread to other areas of the body away from the pancreas. This is sometimes called stage 4 pancreatic cancer.

About receiving Onivyde

Below you’ll find information about key dosage issues.

• When to receive: You’ll receive Onivyde once every 2 weeks.
• If you miss a dose: If you miss an appointment for your Onivyde infusion, call the infusion center right away. They’ll help you reschedule the appointment.
• Length of treatment: Onivyde is meant to be a long-term treatment. If you and your doctor determine that Onivyde is safe and effective for you, you’ll likely receive it long term.

Onivyde side effects

Onivyde can cause mild or serious side effects. The following lists contain some of the key side effects that may occur during treatment with Onivyde. These lists do not include all possible side effects.

Side effects of Onivyde might differ slightly depending on the specific chemotherapy drugs it’s prescribed with.

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

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Onivyde, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Onivyde. To learn about other mild side effects, talk with your doctor or pharmacist or view Onivyde’s prescribing information.

Mild side effects of Onivyde can include:

• abdominal pain
• constipation
• dehydration
• fatigue
• fever
• hair loss
• loss of appetite
• musculoskeletal pain
• nausea or vomiting
• peripheral edema (fluid buildup in the arms or legs)
• stomatitis (inflammation of the lining inside the mouth)
• weight loss
• mild allergic reaction*

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

* For more information about allergic reaction and Onivyde, see “Allergic reaction” below.

Serious side effects

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

Serious side effects and their symptoms can include:

• Interstitial lung disease (a group of conditions that cause scarring of the lungs). Symptoms can include:
  • cough
  • fever
  • shortness of breath
• Severe infection, such as pneumonia, which may lead to sepsis (a life threatening immune system response). Symptoms can include:
  • chills or fever
  • shortness of breath
  • body aches
• Elevated liver enzymes, which may be a sign of liver damage. Symptoms can include:
  • jaundice
  • abdominal pain
  • nausea or vomiting
• Blood clots. Symptoms may vary depending on where the blood clot occurs but can include:
  • shortness of breath
  • skin warmth or discoloration
  • swelling or pain near the affected area
• Low platelet level. Symptoms can include:
  • bleeding more easily
  • bruising more easily
• Low hemoglobin level. Symptoms can include:
  • fatigue
  • shortness of breath
  • skin that looks paler than usual
• Low lymphocyte level, which may not cause symptoms but can increase the risk of infection. This condition can be detected with a blood test.
• Electrolyte imbalances, including low sodium, low potassium, or high potassium. These conditions may not cause symptoms but can be detected with a blood test.
• Risk of serious neutropenia.*
• Risk of serious diarrhea.*
• Severe allergic reaction.†

* Onivyde has a boxed warning for this side effect. This is the most serious warning from the FDA. To learn more, see the “Onivyde precautions” section below.
† For details about allergic reaction and Onivyde, see “Allergic reaction” below.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after receiving Onivyde. This was a rare side effect in clinical trials of this drug.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing

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
• difficulty breathing

Call your doctor right away if you have an allergic reaction to Onivyde, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Onivyde uses

The Food and Drug Administration (FDA) approves prescription drugs such as Onivyde to treat certain conditions. Onivyde may also be used off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

Onivyde for metastatic pancreatic cancer

Onivyde is approved to treat metastatic* pancreatic cancer in certain adults. With this condition, the cancer started in the pancreas but has spread to other areas of the body. This is sometimes called stage 4 pancreatic cancer.

For this purpose, Onivyde is not prescribed by itself. Instead, the drug is prescribed with certain other chemotherapy drugs in the following situations:

• If the cancer has not yet been treated, Onivyde is given with fluorouracil, leucovorin, and oxaliplatin.
• If the cancer has been treated with gemcitabine but did not get better, Onivyde is given with fluorouracil and leucovorin.

You can learn more about metastatic pancreatic cancer by visiting our cancer hub.

* “Metastatic” means the cancer has spread to other areas of the body away from the pancreas. This is sometimes called stage 4 pancreatic cancer.

Onivyde and children

Onivyde is not FDA-approved for use in children. It’s not known for sure whether the drug is safe or effective for children.

Onivyde interactions

Onivyde can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Before starting Onivyde, 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.

Interactions with medications, foods, and supplements

Below is a list of medications, supplements, and foods that can interact with Onivyde. This list does not contain all drugs that may interact with Onivyde. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Alcohol interaction

Alcohol is not known to interact with Onivyde. However, alcohol may worsen certain side effects of the drug. Examples include dehydration, fatigue, and nausea or vomiting.

If you have questions about the safety of drinking alcohol during Onivyde treatment, talk with your doctor or pharmacist.

Onivyde cost and coupons

As with all medications, the cost of Onivyde can vary. 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 Onivyde, or if you need help understanding your insurance coverage, help is available.

To learn more about saving money on prescriptions, check out this article.

Generic version:Onivyde is not available in a generic form. A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics tend to cost less than brand-name drugs.

To learn more about saving money on prescriptions, check out this article.

Onivyde alternatives

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

Certain other chemotherapy drugs are alternatives to Onivyde. Examples of these include:

• other forms of irinotecan, such as Camptosar†
• capecitabine (Xeloda)
• cisplatin†
• paclitaxel (Abraxane)

* “Metastatic” means the cancer has spread to other areas of the body away from the pancreas. This is sometimes called stage 4 pancreatic cancer.
† These drugs are prescribed off-label for this use. Off-label drug use is when a drug approved by the Food and Drug Administration (FDA) is prescribed for a purpose other than what it’s approved for.

Things to consider when receiving Onivyde

If you can become pregnant, consider the following information about pregnancy, birth control, and breastfeeding.

Onivyde and pregnancy

Onivyde should not be received during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before receiving this medication. Your doctor may suggest birth control options to use during treatment with Onivyde.

Onivyde and birth control

Onivyde is not safe to receive during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re receiving Onivyde.

Note: Sex and gender exist on spectrums. Use of the terms “female” and “male” in this article refers to sex assigned at birth.

For females receiving Onivyde

If you’re a female who’s able to become pregnant, you should use effective birth control during Onivyde treatment. And you should continue using birth control for at least 7 months after your last dose of the drug.

For males receiving Onivyde

If you’re a male with a sexual partner who’s able to become pregnant, you should use effective birth control (such as condoms) during Onivyde treatment. You should continue to use birth control for at least 4 months after your last dose of the drug.

Onivyde and breastfeeding

Onivyde should not be received while breastfeeding. You should avoid breastfeeding during Onivyde treatment and for at least 1 month after your last dose of the drug.

If you’re currently breastfeeding or planning to do so, talk with your doctor before receiving Onivyde. Your doctor may recommend other ways to feed your child during treatment with Onivyde.

Common questions about Onivyde

Here are answers to some frequently asked questions about Onivyde.

Is Onivyde part of the NALIRIFOX regimen?

Yes, Onivyde is part of the NALIRIFOX regimen. (A regimen is a treatment plan that specifies the medications and dosages to be administered over a period of time.)

The NALIRIFOX regimen is prescribed for metastatic* pancreatic cancer that has not yet been treated. This regimen consists of Onivyde and three other chemotherapy drugs: fluorouracil, leucovorin, and oxaliplatin.

To learn more about the NALIRIFOX treatment regimen, talk with your doctor.

* “Metastatic” means the cancer has spread to other areas of the body away from the pancreas.

How does Onivyde work?

Onivyde is a chemotherapy drug approved to treat metastatic pancreatic cancer in certain situations. With this condition, the cancer started in the pancreas but has spread to other areas of the body.

Onivyde works by blocking an enzyme (a type of protein) that helps cancer cells grow. By doing this, Onivyde stops new cancer cells from forming and slows down the spread of cancer in the body.

If you have other questions about how Onivyde works, talk with your doctor or pharmacist. You can also view the drug manufacturer’s website.

Does Onivyde cause long-term side effects?

It’s rare but possible. Onivyde may cause side effects that start during treatment but cause problems that continue after treatment ends. An example is interstitial lung disease (a group of conditions that cause scarring of the lungs).

If you have other questions about possible long-term side effects of Onivyde, talk with your doctor or pharmacist.