Bimzelx (bimekizumab-bkzx)

Bimzelx generic or biosimilar

Bimzelx (bimekizumab-bkzx)* is a brand-name biologic drug. It isn’t currently available in a generic or biosimilar version.

Traditional drugs are made from chemicals, while biologic drugs are made from living cells. It’s not possible to make exact copies of biologic drugs. Instead, biosimilars can be made. As with generic versions of traditional drugs, biosimilars tend to cost less than brand-name biologic medications.

* The reason “-bkzx” appears at the end of the drug’s name is to show that the drug is distinct from similar medications that may be created in the future.

Bimzelx dosage

The following information describes Bimzelx 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 for your needs, which may depend on your body weight.

Drug forms and strengths

Bimzelx comes in the following forms and strengths:

• single-dose prefilled syringe in one strength of 160 milligrams per milliliter of solution (mg/mL)
• single-dose prefilled auto-injector in one strength of 160 mg/mL

Both forms of Bimzelx come with an attached needle.

Dosage for plaque psoriasis

Bimzelx is approved to treat plaque psoriasis in certain adults. The recommended dose of Bimzelx is 320 mg given as two injections of 160 mg each. When you start treatment, this dose is given once every 4 weeks for a total of five doses. Then, you’ll likely continue treatment with 320 mg of Bimzelx once every 8 weeks.

If your body weight is 120 kilograms* (about 264 pounds) or more, your doctor may recommend continuing with the 320-mg dose once every 4 weeks.

* For reference, 1 kilogram (kg) is about 2.2 pounds (lb).

How to inject

Bimzelx is given as a subcutaneous injection. Your first dose will likely be given by a healthcare professional at a doctor’s office. They may teach you (or a caregiver) how to administer subsequent doses of the drug at home.

Note that two separate 160-mg injections are needed for each dose of Bimzelx. Each injection should be given using a separate single-dose prefilled syringe or auto-injector. Also, each injection should be given subcutaneously into different areas of your body. For example, you could have one injection under the skin of your thigh and one under the skin of your abdomen. The back of your upper arm may be used if a caregiver or healthcare professional gives your injections.

For more details on how to inject Bimzelx, review the online instructions and videos provided by the drug’s manufacturer.

About Bimzelx treatment

Below you’ll find information about key dosage issues.

• When to inject. You should inject Bimzelx according to your doctor’s instructions. This is typically once every 4 or 8 weeks.
• If you miss a dose. If you miss a dose of Bimzelx, inject the missed dose as soon as possible. Then, continue following your regular dosing schedule. To help prevent missed doses, write a note on your calendar or set an alert on your phone to remind you when your next Bimzelx shot is due.
• Length of treatment. Bimzelx is meant to be a long-term treatment. If you and your doctor determine that Bimzelx is safe and effective for you, they’ll likely prescribe it long term.

Overdose

Do not inject more Bimzelx than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose. To learn about the drug’s side effects, see the “Bimzelx side effects” section just below.

What to do in case you inject too much Bimzelx

If you think you’ve injected too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number or go to the nearest emergency room right away.

Bimzelx side effects

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

For more information about the possible side effects of Bimzelx, 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 Bimzelx, you can do so through MedWatch.

Mild side effects

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

Mild side effects of Bimzelx can include:

• upper respiratory infection, such as the common cold or strep throat
• fungal infection of the mouth, nails, skin, or genitals
• headache
• injection site reactions, such as pain, swelling, and bruising
• acne
• fatigue
• 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 Bimzelx, see “Allergic reaction” below.

Serious side effects

Serious side effects from Bimzelx 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:

• Suicidal thoughts or behaviors. Symptoms can include:
  • new or worsening depression or anxiety
  • thoughts of harming yourself
• Inflammatory bowel diseases, such as ulcerative colitis or Crohn’s disease. Symptoms can include:
  • diarrhea
  • abdominal pain
  • blood or mucus in your stool
  • reduced appetite
• Elevated liver enzymes, which doesn’t cause symptoms but may be a sign of liver problems. Symptoms of liver problems can include:
  • jaundice
  • skin itching
  • nausea and vomiting
  • pain in your abdomen
  • dark-colored urine
• Risk of serious infection. Symptoms can vary depending on the specific infection, but may include fever.
• Severe allergic reaction.*

* For details about allergic reaction and Bimzelx, see “Allergic reaction” below.

Allergic reaction

As with most drugs, some people can have an allergic reaction after a Bimzelx injection. This side effect wasn’t reported in clinical trials of this drug, but can still occur.

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 Bimzelx, 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.

Bimzelx uses

The Food and Drug Administration (FDA) approves prescription drugs such as Bimzelx to treat certain conditions. Bimzelx may also be prescribed 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.

Bimzelx for plaque psoriasis

Bimzelx is FDA-approved to treat moderate to severe plaque psoriasis in adults. Doctors prescribe it for plaque psoriasis that could benefit from systemic treatment (drugs that come as tablets or injections) or phototherapy. Bimzelx is a systemic treatment. Your doctor will decide whether this type of treatment may be beneficial for you.

Plaque psoriasis is a type of psoriasis that causes patches of itchy, flaky skin called plaques.

Psoriasis is an autoimmune condition, which is when your immune system mistakenly attacks your own tissues. With plaque psoriasis, your immune system attacks your skin. This produces inflammation, leading to an overproduction of skin cells that build up and form plaques. Plaques most commonly affect the scalp, arms, legs, and lower back.

You can learn more about plaque psoriasis and the available treatment options in our hub for psoriasis.

Bimzelx and children

Bimzelx is FDA-approved for use in adults. It isn’t known whether the drug is safe or effective for treating plaque psoriasis in children.

Bimzelx interactions

Bimzelx can interact with certain vaccines as well as certain other medications.

Before starting Bimzelx, 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 that can interact with Bimzelx. This list does not contain all drugs that may interact with Bimzelx.

No herbs or supplements have been specifically reported to interact with Bimzelx. However, you should still check with your doctor or pharmacist before using any of these products during Bimzelx treatment.

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

* A live vaccine contains live but weakened pieces of the virus or bacterium it’s meant to defend against.

Alcohol interaction

Alcohol isn’t known to interact with Bimzelx. It’s likely safe to consume alcohol during Bimzelx treatment. If you have questions about how much alcohol is safe for you to drink during Bimzelx treatment, talk with your doctor or pharmacist.

Bimzelx cost

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

Bimzelx Navigate, a patient assistance program and savings card, is available for Bimzelx. For more information and to find out whether you’re eligible for support, visit the program website.

Biosimilar form. Bimzelx is a biologic drug. It isn’t currently available in a generic or biosimilar version.

Traditional drugs are made from chemicals, while biologic drugs are made from living cells. It’s not possible to make exact copies of biologic drugs. Instead, biosimilars can be made. As with generic versions of traditional drugs, biosimilars tend to cost less than brand-name biologic medications.

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

Similar drugs

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 Bimzelx, talk with your doctor. They can tell you about other medications that may work well for you.

The following drugs are similar to Bimzelx:

• brodalumab (Siliq)
• ixekizumab (Taltz)
• secukinumab (Cosentyx)

Things to consider when using Bimzelx

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

Bimzelx and pregnancy

It’s not known whether Bimzelx treatment is safe during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before starting this medication.

If you become pregnant during Bimzelx treatment, tell your doctor. They may recommend stopping Bimzelx. They may also suggest participating in a pregnancy registry. A pregnancy registry collects data from people who took certain medications during pregnancy. The purpose is to determine a drug’s effects (if any) on pregnancy outcomes. For more information, call 877-311-8972 or visit the registry website.

Note: Based on studies of other antibody drugs,* Bimzelx might cross the placenta. This may affect fetal development, especially in the last 3 months of pregnancy.

Specifically, Bimzelx may temporarily weaken an infant’s immune system. This can increase the risk of infection, including from certain live vaccines† that infants may receive. Because of this, your doctor may recommend delaying any live vaccines by at least 4 months for infants who may have been exposed to Bimzelx during fetal development.

If you have questions about these effects, talk with your doctor or pharmacist for more information.

* Bimzelx belongs to a drug class called monoclonal antibodies. These are large, lab-made molecules that are similar to natural antibodies (immune system proteins).
† A live vaccine contains live but weakened pieces of the virus or bacterium it’s meant to defend against. An example is the measles, mumps, and rubella (MMR) vaccine. To learn about childhood vaccines, see this article.

Bimzelx and fertility

It’s not known whether Bimzelx can affect a person’s fertility (ability to become pregnant or make someone else pregnant).

Bimzelx and birth control

It’s not known whether Bimzelx treatment is safe during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs during Bimzelx treatment.

Bimzelx and breastfeeding

It’s not known whether Bimzelx should be used while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before starting this medication.

Common questions about Bimzelx

Here are answers to some frequently asked questions about Bimzelx.

How does Bimzelx work?

With plaque psoriasis, your immune system mistakenly attacks your skin. This produces inflammation, leading to an overproduction of skin cells. These skin cells build up and form patches of itchy, flaky skin called plaques. Plaques most commonly form on the scalp, arms, legs, and lower back.

Bimzelx works by blocking certain cytokines known as interleukin-17A and IL-17F. Cytokines are compounds that naturally occur in the body. They’re important for regulating inflammation and immune responses. By blocking these cytokines, Bimzelx reduces inflammation and stops your immune system from attacking your skin. This helps clear up plaques and also helps prevent the symptoms from coming back.

If you have questions about this, talk with your doctor or pharmacist.

Does Bimzelx cause long-term side effects?

It’s possible for Bimzelx to cause long-term side effects because of the way the drug works. Bimzelx works by weakening your immune system. This means you may develop infections more often than average. Some infections may be acute (short term), while others may be chronic (long term or recurrent).

Most infections that people experienced in the drug’s clinical trials were acute and mild. Examples include strep throat, vaginal yeast infection, and the common cold. Serious infections were also reported in these trials, but were less common. (To learn about mild and serious side effects of this drug, see the “Bimzelx side effects” section above.)

You may have a weakened immune system and an increased risk of infection for as long as your treatment with Bimzelx lasts. And if your doctor stops your treatment, your immune system function may remain low for several months after your last dose. This is because it takes a long time for this drug to leave your system completely.

Talk with your doctor if you have questions about how they’ll monitor you for signs and symptoms of infections with Bimzelx.

Is Bimzelx an effective treatment for plaque psoriasis?

Bimzelx has been shown to be effective at treating plaque psoriasis. For information on how well the drug worked in clinical trials for clearing the skin, see Bimzelx’s prescribing information. You can also visit the manufacturer’s website to learn more about the results of these clinical trials.

As with most drugs, individual results can vary. Talk with your doctor to determine whether Bimzelx would be a possible treatment option for you.