BESPONA injection (inotuzumab ozogamicin) for Acute Lymphoblastic Leukemia

BESPONSA is a prescription medicine used to treat adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). It is not known if BESPONSA is safe to use in children under 18 years of age.

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Before taking BESPONSA, tell your doctor about all of your medical conditions, including if you:

• Have liver disease or a history of liver problems

• Have an infection

• Have ever experienced symptoms such as chills, rash, fever, or breathing problems during or shortly after your BESPONSA infusion

• have signs and symptoms of tumor lysis syndrome, which may be associated with symptoms in the stomach and intestines (for example, nausea, vomiting, diarrhea), kidney (for example, decreased urine, blood in urine), heart (for example, changes in the rhythm), and nerves and muscles (for example, muscular spasms, weakness, cramps), during or shortly after the BESPONSA infusion.

• Have heart problems, including an event of QT prolongation

• have elevations in lipase or amylase enzymes that may be a sign of problems with your pancreas or liver and gallbladder or bile ducts.

• Are pregnant, planning to become pregnant, or if pregnancy is suspected while taking BESPONSA. You should avoid becoming pregnant during treatment with BESPONSA. BESPONSA can cause harm to an unborn baby
  • Females who are able to become pregnant should use effective contraception or birth control during treatment with BESPONSA and for at least 8 months after the last dose
  • Males should also use effective contraception during treatment with BESPONSA and for at least 5 months after the last dose

• Are breastfeeding or planning to breastfeed. Avoid breastfeeding during treatment with BESPONSA and for at least 2 months after the final dose

Use ADBRY exactly as prescribed by your doctor. Your doctor will tell you how much BESPONSA to inject and when to inject it.

For Cycle 1, the recommended total dose of BESPONSA for all patients is 1.8 mg/m2 per cycle, administered as 3 divided doses on Day 1 (0.8 mg/m2), Day 8 (0.5 mg/m2), and Day 15 (0.5 mg/m2). Cycle 1 is for 3 weeks, but may be extended to 4 weeks if the patient achieves a complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), and/or to allow recovery from toxicity.

In patients who achieve a complete remission (CR) or complete remission with incomplete hematologic recover (CRi), the recommended total dose of BESPONSA is 1.5 mg/m2 per cycle, administered as 3 divided doses on Day 1 (0.5 mg/m2), Day 8 (0.5 mg/m2), and Day 15 (0.5 mg/m2). Subsequent cycles are 4 weeks in duration.

In patients who do not achieve a complete remission (CR) or complete remission with incomplete hematologic recover (CRi), the recommended total dose of BESPONSA are 1.8 mg/m2 per cycle given as 3 divided doses on Day 1 (0.8 mg/m2), Day 8 (0.5 mg/m2), and Day 15 (0.5 mg/m2). Subsequent cycles are 4 weeks in duration. Patients who do not achieve a complete remission (CR) or complete remission with incomplete hematologic recover (CRi) within 3 cycles should discontinue treatment.

For patients proceeding to hematopoietic stem cell transplant (HSCT), the recommended duration of treatment with BESPONSA is 2 cycles. A third cycle may be considered for those patients who do not achieve a complete remission (CR) or complete remission with incomplete hematologic recover (CRi) and minimal residual disease (MRD) negativity after 2 cycles.

For patients not proceeding to hematopoietic stem cell transplant (HSCT), additional cycles of treatment, up to a maximum of 6 cycles, may be administered.

The most common side effects are fatigue, bleeding, fever, nausea, headache, low platelet counts (thrombocytopenia), low red blood cell counts (anemia), low white blood cell counts with and without fever (neutropenia, febrile neutropenia, and leukopenia), infection, increases in lab tests measuring liver function, and pain in the abdomen.

• Liver Problems: BESPONSA can cause liver problems that can be fatal, including a condition called veno-occlusive disease (VOD). This condition can happen during treatment with BESPONSA or following subsequent treatment with a stem cell transplant. This condition was more common in patients who had high liver tests or who received dual alkylating agents in preparation for their stem cell transplant. Patients may be at a higher risk of VOD if they:
  • Receive a stem cell transplant after treatment with BESPONSA
  • Have previously received a stem cell transplant
  • Have ongoing or a history of liver problems
  • Are of older age
  • Received multiple treatments for their acute lymphoblastic leukemia ALL prior to BESPONSA
  • Receive a greater number of BESPONSA treatment cycles

Your doctor should perform liver tests periodically during treatment and may modify or stop your treatment with BESPONSA.

• Increased risk of death after stem cell transplant: if you experience any signs and symptoms of infection or liver problems. There is an increased risk of death due to infection and VOD after receiving BESPONSA.

• Low blood cell counts: Low blood cell counts and complications of low blood cell counts, including bleeding and infections, which may be severe and fatal, have happened with BESPONSA. Call your doctor right away if you experience signs and symptoms of infection, unexpected bleeding or bruising blood in your urine or stools, or fever.

• Infusion-related reactions: Inform your doctor right away if you experience fever, chills, rash, or breathing problems during or following your BESPONSA infusion.

• Heart problems: Call your doctor right away if you feel lightheaded, faint, dizzy, or have very slow, very fast, or abnormal heartbeats. Tell your doctor about all the medicines you take.

Refrigerate (2–8°C; 36–46°F) BESPONSA vials and store them in the original carton to protect them from light. Do not freeze. BESPONSA is a cytotoxic drug.

The active substance is inotuzumab ozogamicin. Each vial contains 1 mg inotuzumab ozogamicin. After reconstitution, 1 mL of solution contains 0.25 mg inotuzumab ozogamicin. The other ingredients are sucrose, polysorbate 80, sodium chloride, and tromethamine.