Tafasitamab parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Parenteral formulations of tafasitamab.
Drugs List
Therapeutic Indications
Uses
Large B-cell lymphoma
In combination with lenalidomide followed by monotherapy for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adult patients who are not eligible for autologous stem cell transplant.
Dosage
Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.
Adults
12mg per kg of body weight according to the following schedule:
Cycle 1: tafasitamab infusion on day 1, 4, 8, 15 and 22 of the 28-day cycle.
Cycle 2 and 3: tafasitamab infusion on day 1, 8, 15 and 22 of each 28-day cycle.
Cycle 4 until disease progression: tafasitamab infusion of day 1 and 15 of each 28-day cycle.
In addition, patients should self administer lenalidomide capsules at the recommended starting dose of 25mg daily on days 1 to 21 of each 28-day cycle. Tafasitamab with lenalidomide in combination is given for up to twelve treatment cycles. Treatment with lenalidomide should be stopped after a maximum of twelve treatment cycles of combination therapy. Patients should continue to receive tafasitamab infusions as monotherapy on days 1 and 15 of each 28-day cycle, until dose progression or unacceptable toxicity.
Additional Dosage Information
Dose modifications for adverse reactions
Infusion-related reactions
Grade 2 (moderate): Interrupt tafasitamab infusion immediately and manage signs and symptoms of infusion-related reactions. Once signs and symptoms have resolved or have reduced to Grade 1, resume tafasitamab infusion at no more than 50% of the rate at which the reaction occurred. If the patient does not experience any further infusion-related reactions within 1 hour and vital signs are stable, then the infusion rate may be increased every 30 minutes as tolerated, to the rate at which the reaction occurred.
Grade 3 (severe): Interrupt tafasitamab infusion immediately and manage signs and symptoms of infusion-related reactions. Once signs and symptoms have resolved or have reduced to Grade 1, resume tafasitamab infusion at no more than 25% of the rate at which the reaction occurred. If the patient does not experience any further infusion-related reactions within 1 hour and vital signs are stable, then the infusion rate may be increased every 30 minutes as tolerated, to a maximum of 50% of the rate at which the reaction occurred. If the reaction recurs after the rechallenge, stop the infusion immediately.
Grade 4 (life-threatening): Stop the infusion immediately and permanently discontinue tafasitamab.
Myelosuppression
Platelet count less than 50,000 per microlitre: Withhold tafasitamab and lenalidomide and monitor complete blood count weekly until platelet count has recovered to 50,000 per microlitre or higher. Resume tafasitamab at the same dose and lenalidomide at a reduced dose if platelets return to greater than or equal to 50,000 per microlitre.
Neutrophil count of less than 1000 per microlitre for at least 7 days OR Neutrophil count of less than 1000 per microlitre with an increase of body temperature to 38 degrees celsius or higher OR Neutrophil count less than 500 per microlitre: Withhold tafasitamab and lenalidomide and monitor complete blood count weekly until platelet count has recovered to 1000 per microlitre or higher. Resume tafasitamab at the same dose and lenalidomide at a reduced dose if platelets return to greater than or equal to 1000 per microlitre.
Administration
For intravenous infusion only.
Contraindications
Children under 18 years
Patients not compliant with Pregnancy Prevention Programme
Breastfeeding
Moderate hepatic impairment
Pregnancy
Severe renal impairment
Precautions and Warnings
Females of childbearing potential
History of recurrent infection
Infection
Dehydration
Administration of live vaccines is not recommended
Advise ability to drive/operate machinery may be affected by side effects
Maintain adequate hydration of patient prior / during treatment
Pre-medicate with a corticosteroid, antihistamine and paracetamol
Premedicate all patients with prior infusion related reactions
Consult local policy on the safe use of anti-cancer drugs
Record name and batch number of administered product
Staff: Not to be handled by pregnant staff
Treatment to be administered by or under supervision of specialist
Exclude pregnancy prior to initiation of treatment
Monitor blood counts regularly
Monitor patient for infusion-associated reactions (IARs)
Monitor patients for signs of tumour lysis syndrome
Monitor patients with high tumour burden closely during therapy
Advise patient to report symptoms of infection immediately
Advise patients to seek medical advice if signs of bleeding occur
Consider G-CSF in severe neutropenia / agranulocytosis
Interrupt therapy/reduce infusion rate if infusion-related reactions occur
Discontinue permanently if life threatening infusion reactions occur
Interrupt if neutrophil count <1.0x10 to the power 9/L for at least 7 days
Interrupt if neutrophil count <1.0x10 to the power 9/L with fever
Interrupt treatment if platelet count <50 x 10 to the power of 9/L
Suspend therapy if neutrophils fall below 0.5 x 10 to the power of 9 / L
Female: Contraception required during and for 3 months after treatment
Breastfeeding: Do not breastfeed during & for 3 months after treatment
Advise patient to report signs / symptoms of infusion related reactions
Pregnancy and Lactation
Pregnancy
Tafasitamab is contraindicated during pregnancy.
Use of tafasitamab during pregnancy is contraindicated by the manufacturer. At the time of writing there is limited published information regarding the use of tafasitamab during pregnancy. Potential risks are unknown, however IgG is known to cross the placenta and tafasitamab may cause foetal B-cell depletion. In case of exposure during pregnancy, newborns should be monitored for B-cell depletion and vaccinations with live virus vaccines should be delayed until the B-cell count has recovered.
Lactation
Tafasitamab is contraindicated during breastfeeding.
Use of tafasitamab when breastfeeding and for at least 3 months prior to the start of breastfeeding is contraindicated by the manufacturer. There are not data of the use of tafasitamab in breastfeeding women, however maternal IgG is known to be excreted in milk and therefore a risk to the breastfed infant cannot be excluded.
Side Effects
Abdominal pain
Alopecia
Anaemia
Arthralgia
Aspergillosis
Asthenia
Back pain
Basal cell carcinoma
Bronchitis
Constipation
Cough
Decreased appetite
Diarrhoea
Dysgeusia
Dyspnoea
Erythema
Erythematous rash
Exacerbation of obstructive pulmonary disease
Fatigue
Febrile neutropenia
Gamma glutamyl transferase (GGT) increased
Headache
Hyperbilirubinaemia
Hyperhidrosis
Hypocalcaemia
Hypogammaglobulinaemia
Hypokalaemia
Hypomagnesaemia
Increase in serum transaminases
Increases in hepatic enzymes
Infections
Infusion related reaction
Leukopenia
Lymphopenia
Maculopapular rash
Malaise
Mucosal inflammation
Muscle spasm
Musculoskeletal pain
Nasal congestion
Nausea
Neutropenia
Opportunistic infections
Painful extremities
Paraesthesia
Peripheral oedema
Pneumonia
Pruritic rash
Pruritus
Pyrexia
Raised C-reactive protein
Rash
Sepsis
Serum creatinine increased
Thrombocytopenia
Urinary tract infections
Vomiting
Weight loss
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: March 2022
Reference Sources
Summary of Product Characteristics: Minjuvi 200mg powder for concentrate for solution for infusion. Incyte Biosciences UK Ltd. Revised October 2021.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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