IMPORTANT SAFETY INFORMATION AND USE
What is the most important information I should know about DECNUPAZ?
DECNUPAZ can cause serious side effects, including:
- Liver problems (hepatotoxicity), including veno-occlusive disease (blockage of the small veins in the liver) that can be severe, life-threatening, or may lead to death. Your healthcare provider will do blood tests before each dose of DECNUPAZ and during treatment with DECNUPAZ to check for liver problems. Tell your healthcare provider right away if you develop signs or symptoms of liver problems, including:
- yellowing of the skin or eyes
- fast weight gain
- dark urine
- pain in your stomach (abdomen)
- swelling of your stomach
Your healthcare provider will check you for liver problems during your treatment with DECNUPAZ and may provide treatment for your side effects. Your healthcare provider may also delay or stop treatment with DECNUPAZ if you have severe liver problems.
What should I tell my healthcare provider before receiving DECNUPAZ?
Tell your healthcare provider about all of your medical conditions, including if you:
- have liver problems
- are allergic to sulfites
- have asthma
- have kidney problems
- are pregnant or plan to become pregnant. DECNUPAZ can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if DECNUPAZ passes into your breast milk. Do not breastfeed during treatment with DECNUPAZ and for 1 month after the last dose.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines may affect DECNUPAZ and increase your risk of side effects.
What are the possible side effects of DECNUPAZ?
DECNUPAZ can cause serious side effects, including:
- Liver problems (hepatotoxicity), including veno-occlusive disease (blockage of the small veins in the liver) that can be severe, life-threatening, or may lead to death. Your healthcare provider will do blood tests before each dose of DECNUPAZ and during treatment with DECNUPAZ to check for liver problems. Tell your healthcare provider right away if you develop signs or symptoms of liver problems, including yellowing of the skin or eyes, fast weight gain, dark urine, pain in your stomach (abdomen), or swelling of your stomach.
- Infusion-related reactions (IRR). DECNUPAZ can cause serious, life-threatening infusion-related reactions. Your healthcare provider will give you medicines the day before and on the day of your infusion of DECNUPAZ to help reduce infusion-related reactions. Your healthcare provider will check you for symptoms of infusion-related reactions during your infusion and for at least 4 hours, or longer if needed, after your first infusion, and for at least 1 hour after each of your next infusions. Tell your healthcare provider right away if you develop signs or symptoms of infusion-related reactions, including:
- shortness of breath
- flushing
- fever
- chills
- nausea
- chest pain
- feeling faint or lightheaded
- vomiting
- Fluid retention (edema). DECNUPAZ can cause your body to hold too much fluid during treatment. Your healthcare provider may prescribe water pills (diuretic) if you develop edema. Tell your healthcare provider if you develop new or worsening edema, including:
- swelling of your ankles or legs
- shortness of breath or difficulty breathing
- unusual weight gain
- Sulfite allergic reactions. DECNUPAZ contains sodium metabisulfite, a sulfite that may cause severe, life-threatening allergic reactions in some people. Sulfite allergic reactions are more common in people with asthma than in people without asthma. Get medical help right away if you develop hives; itching; rash; swelling of the eyes, tongue, or lips; chest pain; or trouble breathing or swallowing.
The most common side effects include:
- fluid retention (edema)
- feeling tired
- muscle, bone, and joint pain
- bleeding
- infusion-related reactions
- nausea
- diarrhea
The most common severe abnormal laboratory test results with DECNUPAZ include:
- decreased white blood cell counts
- decreased platelet counts
- decreased red blood cell counts
- increased blood sugar level
Your healthcare provider may decrease your dose, delay your infusion, or permanently stop treatment with DECNUPAZ if you have side effects.
DECNUPAZ may cause fertility problems in males and females, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.
These are not all the possible side effects of DECNUPAZ. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information, including BOXED WARNING, or visit https://www.rxabbvie.com/pdf/decnupaz_pi.pdf.
If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more.
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