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DARZALEX is a brand name for Daratumumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: DARZALEX® (daratumumab for injection) is indicated: • in combination with bortezomib, thalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant. • in combination with lenalidomide and dexamethasone, or with bortezomib,…
Verbatim from this product's HC label. Tap a section to expand.
for management guidelines for these adverse reactions). 1 Dosing Considerations • Darzalex should be administered by a healthcare professional with immediate access to emergency equipment and appropriate medical support to manage infusion-related reactions if they occur.
4 Administration). 3 Reconstitution). 2 Recommended Dose and Dosage Adjustment Combination therapy with bortezomib, thalidomide and dexamethasone (4-week cycle regimen) The Darzalex dosing schedule in Table 1 is for combination therapy with bortezomib, thalidomide and dexamethasone (4-week cycle regimen) for patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT).
3 mg/m2 body surface area) is given twice weekly for 2 weeks (Days 1, 4, 8, and 11) in each cycle. Thalidomide (100 mg) is given daily in each cycle. Dexamethasone (40 mg) is given on Days 1, 2, 8, 9, 15, 16, 22, and 23 of Cycles 1 and 2.
For Cycles 3-4, dexamethasone is given at 40 mg on Days 1-2 and 20 mg on subsequent dosing days (Days 8, 9, 15, 16). Dexamethasone 20 mg is administered on Days 1, 2, 8, 9, 15, 16 in Cycles 5 and 6. For more information on the VTd dose and dosing schedule when administered with Darzalex, see 14 CLINICAL TRIALS.
g. lenalidomide) and for monotherapy as follows: - combination therapy with lenalidomide and low-dose dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for ASCT. - combination therapy with lenalidomide and low-dose dexamethasone for patients with multiple myeloma who have received at least one prior therapy.
- monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy including a PI and an IMiD, or who are refractory to both a PI and an IMiD. The recommended dose of Darzalex is 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule (Table 2): Table 2: Dosing schedule for Darzalex monotherapy and in combination with lenalidomide and dexamethasone (4-week cycle dosing regimens) Weeks Schedule Weeks 1 to 8 weekly (total of 8 doses) Weeks 9 to 24a every two weeks (total of 8 doses) Week 25 onwards until disease progressionb every four weeks a First dose of the every 2-week-dosing schedule is given at Week 9 b First dose of the every 4-week-dosing schedule is given at Week 25 For dosing instructions for medicinal products administered with Darzalex, see 14 CLINICAL TRIALS, and consult the corresponding Product Monographs.
). Monitor complete blood cell counts periodically during treatment according to manufacturer’s prescribing information for background therapies. Monitor patients with neutropenia for signs Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Intravenous (IV) infusion Concentrate for solution for infusion 20 mg/mL L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 20, sorbitol, water for injection.
0 Darzalex (daratumumab for injection) Page 15 of 95 of infection. Darzalex dose delay may be required to allow recovery of blood cell counts (neutrophils or platelets). No dose reduction of Darzalex is recommended. Consider supportive care with transfusions or growth factors as needed.
Immune Infusion-Related Reactions Darzalex can cause severe and/or serious infusion-related reactions (IRRs), including anaphylactic reactions. These reactions can be life-threatening and fatal outcomes have been reported. See 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
In clinical trials, IRRs were reported in approximately 40% of all patients treated with Darzalex. The majority (82%) of infusion-related events occurred at the first infusion and most were Grade 1-2. IRRs can also occur with subsequent infusions.
Four percent of patients had an IRR at more than one infusion. Fatal IRRs were not reported in these trials. Reactions occurred during or after completing Darzalex infusion (see 8 ADVERSE REACTIONS). Most reactions occurred during infusion or within 4 hours of completing Darzalex.
Prior to the introduction of post-infusion medication in clinical trials, IRRs occurred up to 48 hours after infusion. Signs and symptoms may include respiratory symptoms, such as wheezing, larynx and throat tightness and irritation, laryngeal edema, pulmonary edema, and cytokine release syndrome.
and 4 DOSAGE AND ADMINISTRATION for management guidelines for these adverse reactions). 1 Dosing Considerations • Darzalex should be administered by a healthcare professional with immediate access to emergency equipment and appropriate medical support to manage infusion-related reactions if they occur.
4 Administration). 3 Reconstitution). 2 Recommended Dose and Dosage Adjustment Combination therapy with bortezomib, thalidomide and dexamethasone (4-week cycle regimen) The Darzalex dosing schedule in Table 1 is for combination therapy with bortezomib, thalidomide and dexamethasone (4-week cycle regimen) for patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT).
3 mg/m2 body surface area) is given twice weekly for 2 weeks (Days 1, 4, 8, and 11) in each cycle. Thalidomide (100 mg) is given daily in each cycle. Dexamethasone (40 mg) is given on Days 1, 2, 8, 9, 15, 16, 22, and 23 of Cycles 1 and 2.
For Cycles 3-4, dexamethasone is given at 40 mg on Days 1-2 and 20 mg on subsequent dosing days (Days 8, 9, 15, 16). Dexamethasone 20 mg is administered on Days 1, 2, 8, 9, 15, 16 in Cycles 5 and 6. For more information on the VTd dose and dosing schedule when administered with Darzalex, see 14 CLINICAL TRIALS.
g. lenalidomide) and for monotherapy as follows: - combination therapy with lenalidomide and low-dose dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for ASCT. - combination therapy with lenalidomide and low-dose dexamethasone for patients with multiple myeloma who have received at least one prior therapy.
- monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy including a PI and an IMiD, or who are refractory to both a PI and an IMiD. The recommended dose of Darzalex is 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule (Table 2): Table 2: Dosing schedule for Darzalex monotherapy and in combination with lenalidomide and dexamethasone (4-week cycle dosing regimens) Weeks Schedule Weeks 1 to 8 weekly (total of 8 doses) Weeks 9 to 24a every two weeks (total of 8 doses) Week 25 onwards until disease progressionb every four weeks a First dose of the every 2-week-dosing schedule is given at Week 9 b First dose of the every 4-week-dosing schedule is given at Week 25 For dosing instructions for medicinal products administered with Darzalex, see 14 CLINICAL TRIALS, and consult the corresponding Product Monographs.
0 Darzalex (daratumumab for injection) Page 5 of 95 the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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0 Darzalex (daratumumab for injection) Page 7 of 95 Combination therapy with bortezomib, melphalan and prednisone (6-week cycle regimens) The Darzalex dosing schedule in Table 3 is for combination therapy with bortezomib, melphalan and prednisone (6-week cycle regimen) for patients with newly diagnosed multiple myeloma ineligible for ASCT.
The recommended dose of Darzalex is 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule (Table 3): Table 3: Darzalex dosing schedule in combination with bortezomib, melphalan and prednisone ([VMP]; 6-week cycle dosing regimen) Weeks Schedule Weeks 1 to 6 weekly (total of 6 doses) Weeks 7 to 54a every three weeks (total of 16 doses) Week 55 onwards until disease progressionb every four weeks a First dose of the every-3-week dosing schedule is given at Week 7 b First dose of the every-4-week dosing schedule is given at Week 55 Bortezomib is given twice weekly at Weeks 1, 2, 4 and 5 for the first 6-week cycle, followed by once weekly at Weeks 1, 2, 4 and 5 for eight more 6-week cycles.
Melphalan (9 mg/m2) and prednisone (60 mg/m2) are given on days 1-4 of each cycle. For more information on the VMP dose and dosing schedule when administered with Darzalex, see 14 CLINICAL TRIALS. Combination therapy with bortezomib and dexamethasone (3-week cycle regimens) The Darzalex dosing schedule in Table 4 is for combination therapy with bortezomib and dexamethasone (3-week cycle regimen) for patients with multiple myeloma who have received at least one prior therapy.
0 Darzalex (daratumumab for injection) Page 8 of 95 Table 4: Dosing schedule for Darzalex with bortezomib and dexamethasone (3-week cycle dosing regimens) Weeks Schedule Weeks 1 to 9 weekly (total of 9 doses) Weeks 10 to 24a every three weeks (total of 5 doses) Week 25 onwards until disease progressionb every four weeks a First dose of the every 3-week dosing schedule is given at Week 10 b First dose of the every 4-week dosing schedule is given at Week 25 For dosing instructions […]
The most common (≥5%) symptoms were mostly mild to moderate in severity and included cough, and dyspnea. Other symptoms were nasal congestion, throat irritation, bronchospasm, chills, hypotension, headache, pyrexia, chest discomfort, wheezing, rash, urticaria, pruritus, allergic rhinitis, nausea, vomiting, and blurred vision.
1%), were also reported (see 8 ADVERSE REACTIONS). There have also been rare reports of severe IRRs of myocardial infarction and ocular adverse reactions (including choroidal effusion, acute myopia and acute angle closure glaucoma).
Patients should be monitored for symptoms of IRRs. Pre-medicate patients with antihistamines, antipyretics and corticosteroids to reduce the risk of IRRs prior to treatment with Darzalex. Immediately interrupt Darzalex infusion for IRRs of any grade/severity and institute medical management or supportive treatment as needed.
For patients with Grade 1, 2, or 3 reactions, interrupt Darzalex therapy and manage symptoms; reduce the infusion rate when re-starting the infusion. 4 Administration - Management of infusion- related reactions). To reduce the risk of delayed IRRs, administer oral corticosteroids to all patients after each infusion.
g. inhaled corticosteroids, short and long acting bronchodilators) for patients with a history of chronic obstructive pulmonary disease to manage respiratory complications should they occur. Pre- and post-infusion medications may vary when Darzalex is used in combination therapy.
0 Darzalex (daratumumab for injection) Page 16 of 95 ocular symptoms occur, interrupt Darzalex infusion and seek immediate ophthalmologic evaluation prior to restarting Darzalex (see 4 DOSAGE AND ADMINISTRATION). Hypogammaglobulinemia Hypogammaglobulinemia can occur in patients treated with Darzalex.
Immunoglobulin levels should be monitored during treatment with Darzalex. In patients with low immunoglobulin levels, pre-emptive measures according to local guidelines such as infection precautions, antibiotic prophylaxis and immunoglobulin replacement should be considered.
Infections Patients treated with Darzalex in combination with lenalidomide or bortezomib/dexamethasone experienced a higher incidence of infections that could be severe, life-threatening and/or fatal, compared with those treated with lenalidomide or bortezomib/dexamethasone alone (see 8 ADVERSE REACTIONS).
Patients should be monitored for signs and symptoms of infection and treated promptly. Hepatitis B Virus Reactivation Hepatitis B Virus (HBV) reactivation, in some cases fatal, has been reported in patients treated with Darzalex. HBV screening should be performed in all patients before initiation of treatment with Darzalex.
For patients with evidence of positive HBV serology, monitor for clinical and laboratory signs of HBV reactivation during, and for at least six months following the end of Darzalex treatment. Manage patients according to current clinical guidelines.
Consider consulting a hepatitis disease expert as clinically indicated. In patients who develop reactivation of HBV while on Darzalex, suspend treatment with Darzalex and any concomitant steroids, chemotherapy, and institute appropriate treatment.
Resumption of Darzalex treatment in patients whose HBV reactivation is adequately controlled should be discussed with physicians with expertise in managing HBV. Monitoring and Laboratory Tests Interference with indirect antiglobulin test (indirect Coombs test) Daratumumab binds to CD38 found at low levels on red blood cells (RBCs) and may result in a positive indirect Coombs test.
Daratumumab-mediated positive indirect Coombs test may persist for up to 6 […]
0 Darzalex (daratumumab for injection) Page 7 of 95 Combination therapy with bortezomib, melphalan and prednisone (6-week cycle regimens) The Darzalex dosing schedule in Table 3 is for combination therapy with bortezomib, melphalan and prednisone (6-week cycle regimen) for patients with newly diagnosed multiple myeloma ineligible for ASCT.
The recommended dose of Darzalex is 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule (Table 3): Table 3: Darzalex dosing schedule in combination with bortezomib, melphalan and prednisone ([VMP]; 6-week cycle dosing regimen) Weeks Schedule Weeks 1 to 6 weekly (total of 6 doses) Weeks 7 to 54a every three weeks (total of 16 doses) Week 55 onwards until disease progressionb every four weeks a First dose of the every-3-week dosing schedule is given at Week 7 b First dose of the every-4-week dosing schedule is given at Week 55 Bortezomib is given twice weekly at Weeks 1, 2, 4 and 5 for the first 6-week cycle, followed by once weekly at Weeks 1, 2, 4 and 5 for eight more 6-week cycles.
Melphalan (9 mg/m2) and prednisone (60 mg/m2) are given on days 1-4 of each cycle. For more information on the VMP dose and dosing schedule when administered with Darzalex, see 14 CLINICAL TRIALS. Combination therapy with bortezomib and dexamethasone (3-week cycle regimens) The Darzalex dosing schedule in Table 4 is for combination therapy with bortezomib and dexamethasone (3-week cycle regimen) for patients with multiple myeloma who have received at least one prior therapy.
0 Darzalex (daratumumab for injection) Page 8 of 95 Table 4: Dosing schedule for Darzalex with bortezomib and dexamethasone (3-week cycle dosing regimens) Weeks Schedule Weeks 1 to 9 weekly (total of 9 doses) Weeks 10 to 24a every three weeks (total of 5 doses) Week 25 onwards until disease progressionb every four weeks a First dose of the every 3-week dosing schedule is given at Week 10 b First dose of the every 4-week dosing schedule is given at […]