Darzalex Faspro Dosage/Direction for Use

DARZALEX FASPRO is for subcutaneous use only. DARZALEX FASPRO has different dosage and administration instructions than intravenous daratumumab. Do not administer intravenously.
Pre- and post-infusion medications should be administered (see Recommended concomitant medications as follows).
For patients currently receiving daratumumab intravenous formulation, DARZALEX FASPRO subcutaneous formulation may be used as an alternative to the intravenous daratumumab formulation starting at the next scheduled dose.
DARZALEX FASPRO should be administered by a healthcare professional, and the first dose should be administered in an environment where resuscitation facilities are available.
It is important to check the vial labels to ensure that the appropriate formulation (intravenous or subcutaneous formulation) and dose is being given to the patient as prescribed.
Dosage-Adults (≥18 years): Recommended dose for multiple myeloma: The DARZALEX FASPRO dosing schedule in Table 12 is for combination therapy with 4-week cycle regimens (e.g. lenalidomide, pomalidomide, carfilzomib) and for monotherapy as follows: combination therapy with lenalidomide and low-dose dexamethasone for patients with newly diagnosed multiple myeloma ineligible for autologous stem cell transplant (ASCT); combination therapy with lenalidomide or pomalidomide and low-dose dexamethasone for patients with relapsed/refractory multiple myeloma; combination therapy with carfilzomib and low-dose dexamethasone for patients with relapsed/refractory multiple myeloma; monotherapy for patients with relapsed/refractory multiple myeloma.
The recommended dose is DARZALEX FASPRO 1800 mg administered subcutaneously, over approximately 3-5 minutes, according to the following dosing schedule: (see Table 12).

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For dosing instructions of medicinal products administered with DARZALEX FASPRO, see Pharmacology: Pharmacodynamics: Clinical Studies under Actions and manufacturer's prescribing information.
The DARZALEX FASPRO dosing schedule in Table 13 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 is DARZALEX FASPRO 1800 mg administered subcutaneously, over approximately 3-5 minutes, according to the following dosing schedule: (see Table 13).

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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. For information on the VMP dose and dosing schedule when administered with DARZALEX FASPRO, see Pharmacology: Pharmacodynamics: Clinical Studies under Actions.
The DARZALEX FASPRO dosing schedule in Table 14 is for combination therapy with bortezomib, thalidomide and dexamethasone (4-week cycle regimens) for treatment of newly diagnosed multiple myeloma patients eligible for ASCT.
The recommended dose is DARZALEX FASPRO 1800 mg administered subcutaneously, over approximately 3-5 minutes, according to the following dosing schedule: (see Table 14).

Click on icon to see table/diagram/image

For dosing instructions of medicinal products administered with DARZALEX FASPRO, see Pharmacology: Pharmacodynamics: Clinical Studies under Actions and manufacturer's prescribing information.
The DARZALEX FASPRO dosing schedule in Table 15 is for combination therapy with bortezomib and dexamethasone (3-week cycle) for patients with relapsed/refractory multiple myeloma.
The recommended dose is DARZALEX FASPRO 1800 mg administered subcutaneously, over approximately 3-5 minutes, according to the following dosing schedule: (see Table 15).

Click on icon to see table/diagram/image

For dosing instructions for medicinal products administered with DARZALEX FASPRO see Pharmacology: Pharmacodynamics: Clinical Studies under Actions and manufacturer's prescribing information.
Recommended dose for AL amyloidosis: The DARZALEX FASPRO dosing schedule in Table 16 is for combination therapy with bortezomib, cyclophosphamide and dexamethasone (4-week cycle regimen) for patients with AL amyloidosis.
The recommended dose is DARZALEX FASPRO 1800 mg administered subcutaneously, over approximately 3-5 minutes, according to the following dosing schedule: (see Table 16).

Click on icon to see table/diagram/image

For dosing instructions of medicinal products administered with DARZALEX FASPRO, see Pharmacology: Pharmacodynamics: Clinical Studies under Actions and manufacturer's prescribing information.
Missed dose(s): If a planned dose of DARZALEX FASPRO is missed, administer the dose as soon as possible and adjust the dosing schedule accordingly, maintaining the treatment interval.
Dose modifications: No dose reductions of DARZALEX FASPRO are recommended. Dose delay may be required to allow recovery of blood cell counts in the event of hematological toxicity (see Precautions). For information concerning medicinal products given in combination with DARZALEX FASPRO, see manufacturer's prescribing information.
DARZALEX FASPRO and management of infusion-related reactions: In clinical trials, no modification to rate or dose of DARZALEX FASPRO was required to manage infusion-related reactions.
Recommended concomitant medications: Pre-injection medication: Pre-injection medications (oral or intravenous) should be administered to reduce the risk of infusion-related reactions (IRRs) to all patients 1-3 hours prior to every administration of DARZALEX FASPRO subcutaneous injection as follows: Corticosteroid (long-acting or intermediate-acting): Monotherapy: Methylprednisolone 100 mg, or equivalent. Following the second injection, the dose of corticosteroid may be reduced to methylprednisolone 60 mg.
Combination therapy: Administer 20 mg dexamethasone (or equivalent) prior to every DARZALEX FASPRO injection. When dexamethasone is the background-regimen-specific corticosteroid, the dexamethasone treatment dose will instead serve as pre-medication on DARZALEX FASPRO administration days (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions).
Additional background-regimen-specific corticosteroids (e.g. prednisone) should not be taken on DARZALEX FASPRO administration days when patients have received dexamethasone (or equivalent) as a pre-medication.
Antipyretics (paracetamol/acetaminophen 650 to 1000 mg).
Antihistamine (diphenhydramine 25 to 50 mg or equivalent).
Post-injection medication: Administer post-injection medication to reduce the risk of delayed IRRs as follows: Monotherapy: Administer oral corticosteroid (20 mg methylprednisolone or equivalent dose of an intermediate-acting or long-acting corticosteroid in accordance with local standards) on each of the 2 days following all DARZALEX FASPRO injections (beginning the day after the injection).
Combination therapy: Consider administering low-dose oral methylprednisolone (≤20 mg) or equivalent the day after the DARZALEX FASPRO injection.
However, if a background regimen-specific corticosteroid (e.g. dexamethasone, prednisone) is administered the day after the DARZALEX FASPRO injection, additional post-injection medications may not be needed (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions).
If the patient experiences no major IRRs after the first three injections, post-injection corticosteroids (excluding any background regimen corticosteroids) may be discontinued.
Additionally, for patients with a history of chronic obstructive pulmonary disease, consider the use of post-injection medications including short and long-acting bronchodilators, and inhaled corticosteroids. Following the first four injections, if the patient experiences no major IRRs, these inhaled post-injection medications may be discontinued at the discretion of the physician.
Prophylaxis for herpes zoster virus reactivation: Anti-viral prophylaxis should be considered for the prevention of herpes zoster virus reactivation.
Special populations: Pediatrics (17 years of age and younger): The safety and efficacy of DARZALEX FASPRO have not been established in pediatric patients.
Elderly (65 years of age and older): No dose adjustments are considered necessary in elderly patients (see Pharmacology: Pharmacokinetics under Actions, Adverse Reactions).
Renal impairment: No formal studies of daratumumab in patients with renal impairment have been conducted. Based on population pharmacokinetic (PK) analyses, no dosage adjustment is necessary for patients with renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No formal studies of daratumumab in patients with hepatic impairment have been conducted. Changes in hepatic function are unlikely to have any effect on the elimination of daratumumab since IgG1 molecules such as daratumumab are not metabolized through hepatic pathways. No dosage adjustments are necessary for patients with hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Body weight (>120 kg): Limited number of patients with body weight >120 kg have been studied using flat-dose (1800 mg) DARZALEX FASPRO solution for subcutaneous injection and efficacy in these patients has not been established. No dose adjustment based on body weight can currently be recommended.
Cardiac disease: The safety and efficacy of DARZALEX FASPRO have not been established in AL amyloidosis patients with advanced cardiac disease (Mayo Stage IIIB or NYHA Class IIIB or IV).
Administration: DARZALEX FASPRO should be administered by a healthcare professional.
To prevent medication errors, it is important to check the vial labels to ensure that the drug being prepared and administered is DARZALEX FASPRO for subcutaneous injection and not intravenous daratumumab. DARZALEX FASPRO subcutaneous (SC) formulation is not intended for intravenous administration and should be administered via a subcutaneous injection only.
DARZALEX FASPRO is for single use only and is ready to use.
DARZALEX FASPRO is compatible with polypropylene or polyethylene syringe material; polypropylene, polyethylene, or polyvinyl chloride (PVC) subcutaneous infusion sets; and stainless steel transfer and injection needles.
DARZALEX FASPRO should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if opaque particles, discoloration or other foreign particles are present.
Unopened vial: Remove the DARZALEX FASPRO vial from refrigerated storage [2°C-8°C (36°F-46°F)] and equilibrate to ambient temperature [15°C-30°C (59°F-86°F)]. The unpunctured vial may be stored at ambient temperature and ambient light for a maximum of 24 hours. Keep out of direct sunlight. Do not shake. Once the product has been taken out of the refrigerator, it must not be returned to the refrigerator.
Prepare the dosing syringe in controlled and validated aseptic conditions.
To avoid needle clogging, attach the hypodermic injection needle or subcutaneous infusion set to the syringe immediately prior to injection.
Storage of prepared syringe: If the syringe containing DARZALEX FASPRO is not used immediately, store the DARZALEX FASPRO solution for up to 24 hours refrigerated (2-8°C) followed by up to 7 hours at 15°C-30°C (59°F-86°F) and ambient light. Discard if stored more than 24 hours of being refrigerated (2-8°C) or more than 7 hours of being at 15°C-30°C (59°F-86°F), if not used. If stored in the refrigerator, allow the solution to come to ambient temperature before administration.
Method of Administration: Inject 15 mL DARZALEX FASPRO into the subcutaneous tissue of the abdomen approximately 3 inches [7.5 cm] to the right or left of the navel over approximately 3-5 minutes. Do not inject DARZALEX FASPRO at other sites of the body as no data are available.
Injection sites should be rotated for successive injections.
DARZALEX FASPRO should never be injected into areas where the skin is red, bruised, tender, hard or areas where there are scars.
Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by slowing down the injection, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose.
During treatment with DARZALEX FASPRO, do not administer other medications for subcutaneous use at the same site as DARZALEX FASPRO.
Any waste material should be disposed in accordance with local requirements.