Darzalex

Darzalex

daratumumab

Manufacturer:

Janssen-Cilag

Distributor:

DKSH
Concise Prescribing Info
Contents
Daratumumab
Indications/Uses
In combination w/ lenalidomide & dexamethasone in newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant (ASCT) & in patients w/ relapsed or refractory multiple myeloma who have received at least 1 prior therapy. In combination w/ bortezomib, melphalan & prednisone in newly diagnosed multiple myeloma patients who are ineligible for ASCT. In combination w/ bortezomib, thalidomide & dexamethasone in newly diagnosed multiple myeloma patients who are eligible for ASCT. In combination w/ bortezomib & dexamethasone in multiple myeloma patients who have received at least 1 prior therapy. In combination w/ pomalidomide & dexamethasone in multiple myeloma patients who have received at least 2 prior therapies including lenalidomide & a proteasome inhibitor (PI). As monotherapy for multiple myeloma patients, who have received at least 3 prior lines of therapy including a PI & an immunomodulatory agent or who are double-refractory to a PI & an immunomodulatory agent.
Dosage/Direction for Use
Pre-infusion medication: Administer 1-3 hr prior to every infusion of Darzalex. Corticosteroid (long-acting or intermediate-acting): Monotherapy: 100 mg methylprednisolone or equivalent IV. Following the 2nd infusion, the dose of corticosteroid may be reduced to 60 mg. Combination therapy: 20 mg dexamethasone or equivalent. Dexamethasone dose will be as pre-medication on infusion day when it is the background regimen specific corticosteroid. Oral acetaminophen: 650-1,000 mg. Antihistamine: Diphenhydramine 25-50 mg or equiv. Post-infusion medication: Monotherapy: 20 mg methylprednisolone or equiv dose of an intermediate-acting or long-acting corticosteroid on each of the 2 days following Darzalex infusion. Combination therapy: Consider administering low-dose oral methylprednisolone (≤20 mg) or equiv, the day after the Darzalex infusion. If background regimen-specific corticosteroid is administered the day after Darzalex infusion, additional post- infusion medication may not be needed. Prophylaxis of herpes zoster reactivation: Initiate antiviral prophylaxis w/in 1 wk after starting Darzalex & continue for 3 mth following treatment. Newly diagnosed patients ineligible for ASCT (as combination therapy w/ lenalidomide & low-dose dexamethasone) & in patients w/ relapsed/refractory multiple myeloma (as monotherapy or in combination therapy w/ pomalidomide & low-dose dexamethasone) (4-wk cycle regimen) 16 mg/kg as IV infusion. Dosing schedule: Wk 1-8: Wkly (total of 8 doses). Wk 9-24: Every 2 wk (total of 8 doses). 1st dose of the every 2-wk dosing schedule is given at Wk 9. Wk 25 onwards until disease progression: Every 4 wk. 1st dose of the every 4-wk dosing schedule is given at Wk 25. Newly diagnosed multiple myeloma ineligible for ASCT in combination w/ bortezomib, melphalan & prednisone (6-wk cycle regimen) 16 mg/kg as IV infusion. Wk 1-6: Wkly (total of 6 doses). Wk 7-54: Every 3 wk (total of 16 doses). 1st dose of the every-3-wk dosing schedule is given at wk 7. Wk 55 onwards until disease progression: Every 4 wk. 1st dose of the every-4-wk dosing schedule is given at wk 55. Newly diagnosed multiple myeloma eligible for ASCT in combination therapy w/ bortezomib, thalidomide & dexamethasone (4-wk cycle regimen) 16 mg/kg IV infusion. Dosing schedule: Induction phase: Wk 1-8: Wkly (total of 8 doses). Wk 9-16: Every 2 wk (total of 4 doses). 1st dose of the every 2-wk dosing schedule is given at wk 9. Stop for high dose chemotherapy & ASCT. Consolidation phase Wk 1-8: Every 2 wk (total of 4 doses). 1st dose of the every-2-wk dosing schedule is given at wk 1 upon re-initiation of treatment following ASCT. Relapsed/refractory multiple myeloma in combination therapy w/ bortezomib & dexamethasone (3-wk cycle) 16 mg/kg IV infusion. Dosing schedule: Wk 1-9: Wkly (total of 9 doses). Wk 10-24: Every 3 wk (total of 5 doses). 1st dose of the every 3-wk dosing schedule is given at Wk 10. Wk 25 onwards until disease progression: Every 4 wk. 1st dose of the every 4-wk dosing schedule is given at wk 25.
Contraindications
History of severe hypersensitivity.
Special Precautions
Pre-medicate w/ antihistamines, antipyretics & corticosteroids, & frequently monitor patients during the entire infusion. Permanently discontinue treatment if life-threatening (Grade 4) reactions occur. Patients w/ COPD (may require additional post-infusion medications). May cause false-positive result in indirect Coomb's test; type & screen patients prior to starting treatment. Periodically monitor CBC during treatment; patients w/ neutropenia for signs of infection. Thrombocytopenia. May interfere w/ the impact in the determination of complete response & of disease progression in patients w/ IgG κ myeloma protein. Women of reproductive potential should use effective contraception during & for 3 mth after treatment. Pregnancy & lactation. Ped patients.
Adverse Reactions
Infusion reactions, neutropenia, thrombocytopenia. Diarrhea, constipation, nausea, vomiting; peripheral edema, fatigue, asthenia, pyrexia, chills; upper resp tract infection, bronchitis, pneumonia, UTI; decreased appetite, hyperglycemia, hypocalcemia; back pain, muscle spasms, peripheral sensory neuropathy, headache, paresthesia; dyspnea & cough; HTN.
ATC Classification
L01XC24 - daratumumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Darzalex infusion conc 100 mg/5 mL
Packing/Price
1's
Form
Darzalex infusion conc 400 mg/20 mL
Packing/Price
1's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in