Besponsa (inotuzumab ozogamicin)

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Besponsa (inotuzumab ozogamicin)

Besponsa (inotuzumab ozogamicin) is is a medication used for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

How to buy Besponsa (inotuzumab ozogamicin): You can order Besponsa from TheSocialMedwork if the drug has not been approved or is not available in your country.

Oncology Leukemia
Marketing Authorisation Holder Pfizer Limited
Mode of Action CD22-directed antibody-drug conjugate
Administration Intravenous
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA
Strength 1 milligram
Package 1 Vials

What is Besponsa (inotuzumab ozogamicin) for?

Besponsa (inotuzumab ozogamicin) is a CD22-directed antibody-drug conjugate (ADC) used to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)1,2.

How does Besponsa (inotuzumab ozogamicin) work?

The active substance in Besponsa, inotuzumab ozogamicin, is a monoclonal antibody (a type of protein) that has been linked to a small molecule - N-acetyl-gamma-calicheamicin dimethylhydrazide - a cytotoxic agent that once activated provokes the death of cancer cells. The monoclonal antibody has been designed to recognise and attach to CD22 on the cancerous B cells. Once attached, the medicine is taken up by the cell where the cytotoxic agent becomes active, causing breaks in the cell’s DNA and thereby killing the cancer cell3.

Where has Besponsa (inotuzumab ozogamicin) been approved?

Besponsa (inotuzumab ozogamicin) was approved as a monotherapy for relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL)1,2 by:

  • European Medical Agency (EMA), European Union, June 29, 20173

  • Food and Drug Administration (FDA), USA, August 17, 20174

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Besponsa (inotuzumab ozogamicin) taken?

The standard dosage is:

  • Cycle 1 (21 days): Cycle 1 is 3 weeks in duration 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.

    • Day 1: 0.8 mg/m2

    • Day 8 : 0.5 mg/m2

    • Day 15: 0.5 mg/m2

  • Following cycles (28 days)

    • for patients who have achieved CR or CRi

      • Day 1: 0.5 mg/m2

      • Day 8: 0.5 mg/m2

      • Day 15: 0.5 mg/m2

    • for patients who have not achieved CR or CRi

      • Day 1: 0.8 mg/m2

      • Day 8: 0.5 mg/m2

      • Day 15: 0.5 mg/m2

Prior to all infusions, patients need to be pre-medicated with a corticosteroid, antipyretic, and antihistamine1,2.

Besponsa (inotuzumab ozogamicin) is given as an infusion into a vein lasting for at least one hour. The infusions are given on days 1, 8 and 15 of a 3 or 4-week treatment cycle. The treatment may be interrupted or the dose may be reduced if the patient develops certain serious side effects3.

Patients in whom Besponsa (inotuzumab ozogamicin) works well should receive 2 or 3 cycles, after which they can have a stem cell transplant to replace their bone marrow, the only curative treatment. Patients whose treatment works well, but who are not going to receive a stem cell transplant, may receive up to a maximum of 6 cycles of treatment. In patients who do not respond to treatment, Besponsa (inotuzumab ozogamicin) should be stopped after 3 cycles3.

Complete information about Besponsa (inotuzumab ozogamicin) dosage and administration can be found in the resources section1,2.

Note: Consult your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Besponsa (inotuzumab ozogamicin)?

Common adverse reactions

The most common adverse reactions (≥ 20%) listed in the prescribing information include1,2:

  • Thrombocytopenia (low level of platelets)
  • neutropenia (low level of neutrophils, a type of white blood cell)
  • infection
  • anemia (low levels of red blood cells)
  • Leukopenia (low level of number of circulating neutrophil granulocytes)
  • fatigue
  • hemorrhage
  • Pyrexia (fever)
  • Nausea (feeling sick)
  • headache
  • febrile neutropenia (fever in concomitance with a level of neutrophils, a type of white blood cell)
  • transaminases increased (liver damage)
  • abdominal pain
  • gamma-glutamyltransferase increased (high level of liver enzymes)
  • hyperbilirubinemia (high levels of bilirubin, a substance made by the breakdown of red blood cells)
  • Serious adverse reactions

The serious adverse reactions listed in the prescribing information include1,2:

  • infection

  • febrile neutropenia (fever in concomitance with a level of neutrophils, a type of white blood cell)

  • haemorrhage

  • abdominal pain

  • pyrexia (fever)

    • Linver injury: hepatic veno-occlusive disease (VOD)/ Sinusoidal obstruction syndrome (SOS)

  • fatigue (tiredness)

  • heart rhythm disorder: QT interval prolongation

Use in specific populations

Besponsa (inotuzumab ozogamicin) can be fatal for a fetus, it is advised to avoid pregnancies and breast feeding1,2.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1,2.

More Information
Working ingredient inotuzumab ozogamicin
Shipping method Cold chain (temperature controlled)
Package 1
Therapeutic Area Oncology
Oncology Leukemia
Indication Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
Administration Intravenous
Mode of Action CD22-directed antibody-drug conjugate
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA
Marketing Authorisation Holder Pfizer Limited

The Food and Drug Administration (FDA), USA, and European Medical Agency (EMA), European Union, approvals were mainly based on a randomized, open-label study (INO-VATE ALL - NCT01564784) in which Besponsa was tested against chemotherapy. This study involved a total of 326 patients with Philadelphia chromosome-positive B-cell precursor ALL whose disease failed treatment with at least 1 tyrosine kinase inhibitor and standard chemotherapy2.

Results

Among the efficacy outcome measures were complete remission and complete remission with incomplete hematological response (CR/CRi), overall survival (OS), minimal residual disease (MRD) negativity, progression free survival (PFS), and duration of response (DoR). The primary analysis of CR/CRi and MRD negativity was conducted in the initial 218 randomised patients and the analysis of OS, PFS, DoR was conducted in all 326 randomised patients. Patients who responded to treatment could proceed to have a stem cell transplant1.

The CR/CRi was:

  • 80.7% [95% CI: 72.1, 87.7] with Besponsa (inotuzumab ozogamicin)

    • CR: 35.8% [95% CI: 26.8, 45.5]

    • CRi: 45.0% [95% CI: 35.4, 54.8]

  • 29.4% [95% CI: 21.0, 38.8] with chemotherapy

    • CR: 17.4% [95% CI: 10.8, 25.9]

    • CRi: 11.9% [95% CI: 10.8, 25.9]

The MRD negativity for patients achieving CR/CRi was:

  • 78.4% [95% CI: 68.4, 86.5] with Besponsa (inotuzumab ozogamicin)

  • 28.1% [95% CI: 13.7, 46.7] with chemotherapy

The median OS was:

  • 7.7 months [95% CI: 6.0, 9.2] with Besponsa (inotuzumab ozogamicin)

  • 6.7 months [95% CI: 4.9, 8.3] with chemotherapy

The median PFS was:

  • 5.0 months [95% CI: 3.7, 5.6] with Besponsa (inotuzumab ozogamicin)

  • 1.8 months [95% CI: 1.5, 2.2] with chemotherapy

The median DoR was:

  • 3.7 months [95% CI: 2.8, 4.3] with Besponsa (inotuzumab ozogamicin)

  • 0 months with chemotherapy

1. Summary of Product Characteristics [EMA]: Besponsa (inotuzumab ozogamicin) [PDF]
    Pfizer, July 2017.

2. Summary of Product Characteristics [FDA]: Besponsa (inotuzumab ozogamicin) [PDF]
    Pfizer, Aug 2017

3. EMA. Human Medicines: Besponsa (inotuzumab ozogamicin)
    cited September 2017.


Shipping Type Cold Chain
Shipping method Cold chain (temperature controlled)
Dynamic Weight No
This content has been reviewed by our medical doctor Jan de Witt.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.