Approved Use & Safety Info
Approved Use
Important Safety Information
Approved Use
What is BLENREP?
BLENREP is a prescription medicine used in combination with the medicines bortezomib and dexamethasone to treat adults with multiple myeloma who:
- have received at least 2 prior treatments, including a proteasome inhibitor and an immunomodulatory agent, and
- their cancer has come back or did not respond to prior treatment
It is not known if BLENREP is safe and effective in children.
Important Safety Information
What is the most important information I should know about BLENREP?
BLENREP can cause serious side effects, including:
- Eye problems. Eye problems are common with BLENREP and can also be severe. BLENREP can cause changes to the surface of your eye, which can lead to symptoms of eye problems, including:
- decreased vision
- blurred vision
- dry eyes
- sensitivity to light
- feeling like something is in your eyes
- eye irritation
- eye pain
Ulcers on the surface of the eye (corneal ulcers), including with infection, may also happen during treatment with BLENREP.
Tell your healthcare provider right away if you notice any new or worsening eye symptoms or vision changes during treatment with BLENREP.
Your healthcare provider will refer you to an eye care specialist (such as an ophthalmologist or optometrist) to check your eyes before you start treatment, before you receive each dose of BLENREP, and as needed for any new or worsening eye problems. It is important that you:
- Keep all of your eye care appointments because some changes can happen without symptoms and may only be seen on an eye exam
- Use preservative‑free artificial tears at least 4 times per day starting with your first infusion and continuing until the end of treatment with BLENREP
- Avoid wearing contact lenses during treatment with BLENREP unless directed by your eye care specialist
- Use caution when driving or operating machinery because BLENREP may cause changes to your vision
Because of the risk of eye problems, BLENREP is available only through a restricted program called the BLENREP Risk Evaluation and Mitigation Strategy (REMS). Your healthcare provider will give you the BLENREP REMS Patient Guide, which describes the risk of eye problems, and will explain the REMS program to you. To receive BLENREP, you must enroll in the REMS program and receive eye exams during treatment. See “What are the possible side effects of BLENREP?” for more information about side effects.
What are the possible side effects of BLENREP?
BLENREP can cause serious side effects, including:
- See “Eye Problems” in “What is the most important information I should know about BLENREP?”
- Decrease in platelets (thrombocytopenia) is common with BLENREP and can also be severe. 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 as needed. Tell your healthcare provider if you get any bleeding or bruising during treatment with BLENREP
The most common side effects of BLENREP when given with bortezomib and dexamethasone include:
- See “Eye problems” in “What is the most important information I should know about BLENREP?”
- upper respiratory tract infection
- liver problems
- diarrhea
- tiredness
- pneumonia
- cataract
- COVID-19
The most common severe abnormal blood test results during treatment with BLENREP include decreases in platelets, white blood cells, and hemoglobin, and increases in certain liver enzymes.
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, or cough.
Your healthcare provider may decrease your dose, temporarily stop, or completely stop treatment with BLENREP if you get serious side effects.
BLENREP may affect fertility in males and females, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.
These are not all of the possible side effects of BLENREP.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.
Before receiving BLENREP, tell your healthcare provider about all of your medical conditions, including if you:
- have or had vision or eye problems
- have or had 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 will do a pregnancy test before you start treatment with BLENREP
- 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:
- 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
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Please see full Prescribing Information, including Boxed Warning and Medication Guide for BLENREP.
