Inotuzumab

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

• Inotuzumab is available under the following different brand names: Besponsa 

Common side effects of Inotuzumab include:

• Low platelet counts (thrombocytopenia),
• Low white blood cell counts (neutropenia, leukopenia),
• Infection,
• Anemia,
• Fatigue,
• Bleeding,
• Fever,
• Nausea,
• Headache,
• Febrile neutropenia,
• Transaminases increased,
• Abdominal pain, diarrhea,
• Constipation,
• Vomiting,
• Swelling and sores inside the mouth,
• Chills,
• Gamma-glutamyl transferase increased, and
• Too much bilirubin in the blood

Serious side effects of Inotuzumab include:

• Black, tarry stools.
• blood in the urine or stools.
• chest pain.
• cough or hoarseness.
• coughing up blood.
• difficulty in breathing or swallowing.
• increased menstrual flow or vaginal bleeding.
• nosebleeds.

Rare side effects of Inotuzumab include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, lyophilized powder for reconstitution

• 0.9 mg/vial

Acute Lymphoblastic Leukemia

Adult dosage

• Cycle 1 for all patients
  • Total dose of inotuzumab: 1.8 mg/m² per 21-day cycle, administered as 3 divided doses
  • Day 1: 0.8 mg/m²
  • Day 8 and 15: 0.5 mg/m²
  • Duration of cycle 1 is 21 days; may extend to 28 days (. g, 7-day treatment-free interval starting on day 21) if the patient achieves a complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), and/or allows recovery from toxicity
  • CR is defined as below 5% blasts in the bone marrow and absence of peripheral blood leukemic blasts, full recovery of peripheral blood counts (platelets above 100 for 10^9/L and absolute neutrophil counts [ANC] above 1 for 10^9/L), and resolution of any extramedullary disease
  • CRi is defined as below 5% blasts in bone marrow and absence of peripheral blood leukemic blasts, incomplete recovery of peripheral blood counts (platelets below 100 into 10^9/L and/or ANC below 1 into 10^9/L), and resolution of any extramedullary disease
• Patients who achieve a CR or CRI
  • 1.5 mg/m² per 28-day cycle, including a 7-day treatment-free interval starting on day 21, administered as 3 divided doses
  • Day 1, 8, and 15: 0.5 mg/m² Intravenous
• Patients who do not achieve a CR or CRi
  • Total dose of inotuzumab is 1.8 mg/m² per 28-day cycle, including a 7-day treatment-free interval starting on day 21 administered as 3 divided doses
  • Day 1: 0.8 mg/m² Intravenous
  • Day 8 and 15: 0.5 mg/m² Intravenous
  • Patients who do not achieve a CR or CRi below 3 cycles should discontinue treatment

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Inotuzumab has severe interactions with no other drugs.
• Inotuzumab has serious interactions with at least 123 other drugs.
• Inotuzumab has moderate interactions with the following drugs:
  • albuterol
  • chloroquine
  • deutetrabenazine
  • fostemsavir
  • gadobenate
  • gemtuzumab
  • hydroxyzine
  • ofatumumab SC
  • osilodrostat
  • oxaliplatin
  • ozanimod
  • ponesimod
  • selpercatinib
  • siponimod
  • trastuzumab
  • trastuzumab deruxtecan
  • triclabendazole
  • valentine
  • voclosporin
• Inotuzumab has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Inotuzumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Inotuzumab?”

Cautions

• Hepatotoxicity, including VOD, was reported; monitor closely for signs and symptoms of VOD (.g, increased total bilirubin, hepatomegaly, rapid weight gain, ascites) (see Black Box Warnings)
• Increase risk of posttransplant no relapse mortality (see Black Box Warnings)
• QT prolongation reported; caution with history of or predisposition to QT prolongation, currently taking medications known to prolong QT interval or electrolyte disturbances; obtain baseline ECG and electrolytes levels; monitor periodically during treatment
• In animal studies, embryofetal harm may occur when administered to a pregnant woman (see Pregnancy)
• Myelosuppression
  • Risk of myelosuppression; complications, including infections and bleeding/hemorrhagic events, observed; monitor complete blood cell counts before initiating; monitor for signs/symptoms of infection, bleeding/hemorrhage, or other effects of myelosuppression during treatment; if necessary, administer prophylactic anti-infectives and use surveillance testing during and after treatment
  • Management of severe infection, bleeding/hemorrhage, or other effects of myelosuppression, including severe neutropenia or thrombocytopenia, may require dosing interruption, dose reduction, or permanent discontinuation
• Infusion-related reactions
  • Infusion-related reactions may occur; premedicate with a corticosteroid, antipyretic, and antihistamine before dosing
  • Monitor closely during and for at least 1 hour after the end of infusion for the potential onset of infusion-related reactions (.g, fever, chills, rash, or breathing problems); interrupt the infusion and institute appropriate medical management if an infusion-related reaction occurs
  • See Dosage Modifications

Pregnancy and Lactation

• Based on its mechanism of action and findings from animal studies, inotuzumab can cause embryofetal harm when administered to a pregnant woman; no available data for use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage
• If used during pregnancy, or if the patient becomes pregnant while taking inotuzumab, advise the patient of the potential risk to a fetus
• Females and Males of Reproductive Potential
• Based on findings in animals, inotuzumab may impair fertility in males and females of reproductive potential
• Pregnancy testing
  • Verify the pregnancy status of females of reproductive potential before initiating inotuzumab
• Contraception
  • Advise females of reproductive potential to avoid becoming pregnant while receiving inotuzumab
  • Advise females of reproductive potential to use effective contraception during treatment with inotuzumab and for at least 8 months after the last dose
  • Advise males with female partners of reproductive potential to use effective contraception during treatment with inotuzumab and for at least 5 months after the last dose
• Lactation
  • Unknown if distributed in human breast milk
  • No data on the presence of inotuzumab ozogamicin or its metabolites in human milk, its effects on the breastfed infant, or its effects on milk production
  • Because of the potential for adverse reactions in breastfed infants, advise women not to breastfeed during treatment with inotuzumab and for at least 2 months after the last dose