Tafasitamab

Tafasitamab is a prescription medication used in combination with lenalidomide for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) , in adults who are not eligible for autologous stem cell transplantation.

• Tafasitamab is available under the following different brand names: Monjuvi, tafasitamab-cxix

Common side effects of Tafasitamab include:

• low white blood cells (neutropenia)
• fatigue
• anemia
• diarrhea
• low blood platelets (thrombocytopenia)
• cough
• fever
• swelling of extremities
• respiratory tract infection
• decreased appetite
• constipation
• nausea
• vomiting
• shortness of breath
• bronchitis
• low blood potassium (hypokalemia)
• back pain
• muscle spasms

Serious side effects of Tafasitamab include:

• sore throat, fever, chills, cough, burning or painful urination, or other signs of infection
• fever or unusual bruising or bleeding
• pale skin, fatigue
• shortness of breath
• low blood cell counts

Rare side effects of Tafasitamab 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, coordination loss, 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

• 200 mg/vial

Diffuse large B-cell lymphoma

Adult dosage

• Each cycle is of 28 days
• Cycle 1
  • Days 1 to 21: lenalidomide 25 mg orally once a day
  • Days 1, 4, 8, 15, and 22: tafasitamab 12 mg/kg IV
• Cycles 2 and 3
  • Days 1 to 21: lenalidomide 25 mg orally once a day
  • Days 1, 8, 15, and 22: tafasitamab 12 mg/kg IV
• Cycle 4 and thereafter
  • Days 1 to 21: lenalidomide 25 mg orally once a day
  • Days 1 and 15: tafasitamab 12 mg/kg IV
  • Administer tafasitamab in combination with lenalidomide for up to 12 cycles, then continue tafasitamab as monotherapy until disease progression or unacceptable toxicity

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.

• Tafasitamab has no noted severe interactions with any other drugs
• Tafasitamab has no noted serious interactions with any other drugs
• Tafasitamab has no noted moderate interactions with any other drugs
• Tafasitamab has no noted minor interactions with any 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 the products you use. 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, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• May cause infusion-related reactions; signs and symptoms included chills, flushing, dyspnea, and hypertension
• Severe myelosuppression, including neutropenia, thrombocytopenia, and anemia, has been reported; monitor CBC count and monitor patients with neutropenia for signs of infection; consider granulocyte colony-stimulating factor administration
• Fatal and serious infections, including opportunistic infections, occurred; monitor for signs and symptoms of infection and manage infections appropriately
• May cause fetal B-cell depletion when administered to pregnant women; concomitant use of Tafasitamab with lenalidomide is contraindicated in pregnant women

Pregnancy and Lactation

• Based on its mechanism of action, tafasitamab may cause fetal B-cell depletion when administered to pregnant women
• No available data on use in pregnant women to evaluate for a drug-associated risk
• Animal reproductive toxicity studies have not been conducted
• Lenalidomide
  • Contraindicated during pregnancy
  • Tafasitamab is used in combination with lenalidomide for up to 12 cycles
  • Refer to lenalidomide prescribing information for additional information (e.g., contraception, pregnancy testing)
  • Lenalidomide is only available through a risk evaluation and mitigation strategy (REMS) program
• Contraception
  • Women of reproductive potential: Use effective contraception during treatment and at least 3 months after the final dose
• Fetal/neonatal adverse reactions
  • IgG monoclonal antibodies are transferred across the placenta
  • May cause depletion of fetal CD19-positive immune cells
  • Defer administering live vaccines to neonates and infants exposed to Tafasitamab in utero until completing a hematology evaluation
• Lactation
  • There is no data on the presence of tafasitamab in human milk or its effects on the breastfed child or milk production
  • Maternal immunoglobulin G is known to be present in human milk
  • Effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant are unknown
  • Advise women not to breastfeed during treatment and for at least 3 months after the final dose
  • Refer to lenalidomide prescribing information for additional information