Blincyto | Blincyto package insert | 100% good quality

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Blincyto (blinatumomab) is used to treat a certain type of acute lymphoblastic leukemia in adults and children. Blincyto package insert.

Description

What is Blincyto? | Blincyto | Blincyto package insert | 100% good quality

Blincyto (blinatumomab) is used to treat a certain type of acute lymphoblastic leukemia in adults and children.

Blincyto is given after other cancer treatments have been tried without success.

Blincyto was approved by the US Food and Drug Administration (FDA) on an “accelerated” basis. In clinical studies, some people responded to this medicine, but further studies are needed. Blincyto package insert. Blincyto package insert.

Acute lymphoblastic leukemia is a cancer of the blood in which a particular kind of white blood cell is growing out of control.

Blincyto (blinatumomab) for injection is a bispecific CD19-directed CD3 T- cell engager indicated for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Blincyto package insert.

What are side effects for Blincyto?

Common side effects of Blincyto include:

INDICATIONS

MRD-Positive B-Cell Precursor ALL

BLINCYTO is indicated for the treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children. Blincyto package insert.

This indication is approved under accelerated approval based on MRD response rate and hematological relapse-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Blincyto package insert.

Relapsed Or Refractory B-Cell Precursor ALL

BLINCYTO is indicated for the treatment of relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children.

DOSAGE AND ADMINISTRATION

Treatment Of MRD-Positive B-Cell Precursor ALL

  • A treatment course consists of 1 cycle of BLINCYTO for induction followed by up to 3 additional cycles for consolidation.
  • A single cycle of treatment of BLINCYTO induction or consolidation consists of 28 days of continuous intravenous infusion followed by a 14-day treatment-free interval (total 42 days).
  • See Table 1 for the recommended dose by patient weight and schedule. Patients weighing 45 kg or more receive a fixed-dose. For patients weighing less than 45 kg, the dose is calculated using the patient’s body surface area (BSA). Blincyto package insert.

DESCRIPTION

BLINCYTO (blinatumomab) is a bispecific CD19-directed CD3 T-cell engager that binds to CD19 (expressed on cells of B-lineage origin) and CD3 (expressed on T cells). BLINCYTO is produced in Chinese hamster ovary cells. It consists of 504 amino acids and has a molecular weight of approximately 54 kilodaltons. Blincyto package insert.

Each BLINCYTO package contains 1 vial BLINCYTO and 1 vial IV Solution Stabilizer.

BLINCYTO is supplied in a single-dose vial as a sterile, preservative-free, white to off-white lyophilized powder for intravenous administration. Each single-dose vial of BLINCYTO contains 35 mcg blinatumomab, citric acid monohydrate (3.35 mg), lysine hydrochloride (23.23 mg), polysorbate 80 (0.64 mg), trehalose dihydrate (95.5 mg), and sodium hydroxide to adjust pH to 7.0. After reconstitution with 3 mL of preservative-free Sterile Water for Injection, USP, the resulting concentration is 12.5 mcg/mL blinatumomab. Blincyto package insert.

IV Solution Stabilizer is supplied in a single-dose vial as a sterile, preservative-free, colorless to slightly yellow, clear solution. Each single-dose vial of IV Solution Stabilizer contains citric acid monohydrate (52.5 mg), lysine hydrochloride (2283.8 mg), polysorbate 80 (10 mg), sodium hydroxide to adjust pH to 7.0, and water for injection. Blincyto package insert.

Who should not receive BLINCYTO®?

  • Do not receive BLINCYTO® if you are allergic to blinatumomab or to any of the ingredients of BLINCYTO®.

What should I avoid while receiving BLINCYTO®?

  • Do not drive, operate heavy machinery, or do other dangerous activities while you are receiving BLINCYTO® because BLINCYTO® can cause neurological symptoms such as dizziness, seizures, and confusion. Blincyto package insert.

Before receiving BLINCYTO®, tell your health care provider about all of your medical conditions, including if you or your child:

  • have a history of neurological problems, such as seizures, confusion, trouble speaking or loss of balance
  • have an infection. Blincyto package insert.
  • have ever had an infusion reaction after receiving BLINCYTO® or other medications
  • have a history of radiation treatment to the brain, or chemotherapy treatment
  • are scheduled to receive a vaccine. You should not receive a “live vaccine” within 2 weeks before you start treatment with BLINCYTO®, during treatment, and until your immune system recovers after you receive your last cycle of BLINCYTO®. If you are not sure about the type of vaccine, ask your health care provider.
  • are pregnant or plan to become pregnant. BLINCYTO® may harm your unborn baby. Tell your health care provider if you become pregnant during treatment with BLINCYTO®. Blincyto package insert.
    • If you are able to become pregnant, your health care provider should do a pregnancy test before you start treatment with BLINCYTO®.
    • Females who are able to become pregnant should use an effective form of birth control during treatment with BLINCYTO®, and for at least 48 hours after the last dose of BLINCYTO®.
  • are breastfeeding or plan to breastfeed. It is not known if BLINCYTO® passes into your breast milk. You should not breastfeed during treatment with BLINCYTO® and for at least 48 hours after your last treatment.
  • Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
  • BLINCYTO® may cause serious side effects, including:
    • Infections. BLINCYTO® may cause life-threatening infections that may lead to death. Tell your health care provider right away in case you develop any signs or symptoms of an infection.
    • Low white blood cell counts (neutropenia). Neutropenia is common with BLINCYTO® treatment and may sometimes be life-threatening. Low white blood cell counts can increase your risk of infection. Your health care provider will do blood tests to check your white blood cell counts during treatment with BLINCYTO®. Tell your health care provider right away if you get a fever.
    • Abnormal liver blood test. Your health care provider will do blood tests to check your liver before you start BLINCYTO® and during treatment with BLINCYTO®.
    • Inflammation of the pancreas (pancreatitis). Pancreatitis may happen in patients treated with BLINCYTO® and corticosteroids. It may be severe and lead to death. Tell your health care provider right away if you have severe abdominal pain that does not go away. The pain may happen with or without nausea and vomiting.

 

  • Your health care provider will do blood tests during treatment to check for side effects. Blincyto package insert.
  • The most common side effects of BLINCYTO® include:
    • Infections
    • Fever
    • Headache
    • Low red blood cell count (anemia)
    • Low white blood cell count (neutropenia)
    • Low white blood cell count with fever (febrile neutropenia)
    • Low platelet count (thrombocytopenia)
    • Reactions related to infusion of the medicine such as face swelling, low blood pressure, and high blood pressure (infusion-related reactions)
  • These are not all the possible side effects of BLINCYTO®.
  • Call your health care provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • Please read the accompanying Medication Guide before you or your child receives BLINCYTO® and before each BLINCYTO® infusion and discuss it with your doctor. Blincyto package insert.

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