UNDERSTANDING RISKS & SIDE EFFECTS

The risk information provided here is not comprehensive. To learn more, talk to your healthcare provider or pharmacist, or see the FDA-approved product labeling, including the Medication Guide.

What is the most important information I should know about BLENREP?

Before you receive BLENREP, you must read and agree to all of the instructions in the BLENREP Risk Evaluation and Mitigation Strategy (REMS). Before prescribing BLENREP, your healthcare provider will explain the BLENREP REMS to you and have you sign the Patient Enrollment Form. Learn more about the BLENREP REMS.

BLENREP can cause serious side effects, including:

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EYE PROBLEMS

Eye problems are common with BLENREP. BLENREP can cause changes to the surface of your eye that can lead to dry eyes, blurred vision, worsening vision, severe vision loss, and corneal ulcer. Tell your healthcare provider if you have any vision changes or eye problems during treatment with BLENREP.

  • Your healthcare provider will send you to an eye specialist to check your eyes before you start treatment with BLENREP, prior to each dose of BLENREP, and for worsening symptoms of eye problems.
  • Even if your vision seems fine, it is important that you get your eyes checked during treatment with BLENREP because some changes can happen without symptoms and may only be seen on an eye exam.
  • You should use preservative-free lubricant eye drops at least 4 times per day during treatment with BLENREP as instructed by your healthcare provider.
  • You should use caution when driving or operating machinery as BLENREP may affect your vision.
  • Avoid wearing contact lenses during treatment with BLENREP unless directed by your eye specialist.
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DECREASE IN PLATELETS (THROMBOCYTOPENIA)

Decrease in platelets (thrombocytopenia) is common with BLENREP, and can also be serious. Platelets are a type of blood cell that help your blood to clot. Your healthcare provider will check your blood cell counts before you start treatment with BLENREP and during treatment. Tell your healthcare provider if you have bleeding or bruising during treatment with BLENREP.

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INFUSION-RELATED REACTIONS

Infusion-related reactions are common with BLENREP, and can also be serious. Tell your healthcare provider or nurse right away if you get any of the following signs or symptoms of an infusion-related reaction while receiving BLENREP:

  • chills or shaking
  • redness of your face (flushing)
  • itching or rash
  • shortness of breath, cough, or wheezing
  • swelling of your lips, tongue, throat, or face
  • dizziness
  • feel like passing out
  • tiredness
  • fever
  • feel like your heart is racing (palpitations)

The most common side effects of BLENREP include vision or eye changes such as findings on eye exam (keratopathy), decreased vision or blurred vision, nausea, low blood cell counts, fever, infusion-related reactions, tiredness, and changes in kidney or liver function blood tests.

Tell your healthcare provider right away if you get new or worsening unexplained signs or symptoms of lung problems, including shortness of breath, chest pain, and cough.

Before receiving BLENREP, tell your healthcare provider about all of your medical conditions, including if you:

  • have a history of vision or eye problems.
  • have bleeding problems or a history of bleeding problems.
  • are pregnant or plan to become pregnant. BLENREP can harm your unborn baby. Females who are able to become pregnant: Your healthcare provider may do a pregnancy test before you start treatment with BLENREP. You should use effective birth control during treatment with BLENREP and for 4 months after the last dose. Talk to your healthcare provider about birth control methods you can use during this time. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with BLENREP. Males with female partners who are able to become pregnant should use effective birth control during treatment with BLENREP and for 6 months after the last dose.
  • are breastfeeding or plan to breastfeed. It is not known if BLENREP passes into your breast milk. Do not breastfeed during treatment with BLENREP and for 3 months after the last dose.
  • BLENREP may affect fertility in males and females. Talk to your healthcare provider if this is a concern for you.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

These are not all the possible side effects of BLENREP.

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.

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