Pivekimab sunirine

Pivekimab sunirine is used in adults to treat a type of blood cancer called blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Pivekimab sunirine may also be used for other reasons not mentioned in this medication guide.

Pivekimab sunirine is given once every 3 weeks through an infusion into a vein that lasts 15 to 30 minutes. A healthcare provider will administer this injection and will decide how many treatments you will have.

Doses are determined by your weight. Your dose may change if you gain or lose weight.

You may receive other medicines the day before and on the day of your infusion to help prevent some serious side effects. Continue taking these medicines for as long as your doctor has prescribed.

You will need regular blood tests to check how your liver is functioning. Your treatment may be delayed, reduced, or stopped permanently based on the results.

Pivekimab sunirine can lead to liver issues. Your liver function will need to be checked before and during treatment. Contact your doctor if you experience loss of appetite, nausea, vomiting, stomach pain (in the upper right side), tiredness, itching, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Tell your doctor if you have or have ever had:

• asthma or sulfite allergy; or
• liver or kidney disease.

Pivekimab sunirine can harm an unborn baby if the mother or the father is using pivekimab sunirine.

• If you are a woman, you may need a pregnancy test to confirm that you are not pregnant. Use birth control while using this medicine and for at least 7 months after your last dose.
• If you are a man, use birth control if your sex partner can become pregnant. Continue using birth control for at least 4 months after your last dose.
• Tell your doctor if you become pregnant or think you might be pregnant.

Do not breastfeed while using this medicine, and for at least 1 month after your last dose.

Get emergency medical help if you notice signs of an allergic reaction: hives, itching, rash, chest pain, difficulty breathing, trouble swallowing, or swelling of your face, lips, tongue, or throat.

Some side effects may happen during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Pivekimab sunirine may cause serious side effects. Call your doctor right away if you experience:

• fluid retention—shortness of breath (even while lying down), swelling, rapid weight gain (especially in your face and midsection); or
• liver problems—loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your treatments may be delayed or permanently stopped if you have certain side effects.

Common side effects of pivekimab sunirine may include:

• a reaction during the injection;
• swelling;
• feeling tired;
• muscle, bone, or joint pain;
• nausea, diarrhea;
• bleeding that will not stop; or
• abnormal blood tests.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Call your doctor for instructions if you miss an appointment for your pivekimab sunirine injection.

In a medical setting, an overdose will be treated promptly.

Follow your doctor's instructions regarding any limits on food, drinks, or activities.

Sometimes it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially:

• nefazodone;
• cancer medicine--ceritinib, idelalisib, ribociclib, tucatinib;
• an antibiotic--clarithromycin, telithromycin;
• antifungal medicine--itraconazole, ketoconazole, posaconazole, voriconazole;
• antiviral medicine for HIV or hepatitis C--boceprevir, cobicistat, dasabuvir, elvitegravir, indinavir, lopinavir/ritonavir, nelfinavir, ombitasvir, paritaprevir, saquinavir, telaprevir, tipranavir.

This list is not complete. Other drugs may affect pivekimab sunirine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.