Darzalex

Darzalex Liều dùng/Hướng dẫn sử dụng

daratumumab

Nhà sản xuất:

Janssen-Cilag
Thông tin kê toa chi tiết tiếng Anh
Dosage/Direction for Use
DARZALEX should be administered by a healthcare professional, in an environment where resuscitation facilities are available.
Posology: Pre and post infusion medications should be administered to reduce the risk of infusion related reactions (IRRs) with daratumumab. See Recommended concomitant medications, Management of infusion related reactions as follows and PRECAUTIONS.
Dose: Standard dosing for monotherapy and in combination with lenalidomide (4 week cycle regimen):
The recommended dose is DARZALEX 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule in Table 4. (See Table 4.)


Click on icon to see table/diagram/image


For dose and schedule of medicinal products administered with DARZALEX, see PHARMACOLOGY: PHARMACODYNAMICS: PHARMACODYNAMIC PROPERTIES under ACTIONS and the corresponding Summary of Product Characteristics.
Modified dosing schedule in combination with bortezomib (3 week cycle regimen): The recommended dose is DARZALEX 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule in Table 5. (See Table 5.)


Click on icon to see table/diagram/image


For dose and schedule of medicinal products administered with DARZALEX, see PHARMACOLOGY: PHARMACODYNAMICS: PHARMACODYNAMIC PROPERTIES under ACTIONS and the corresponding Summary of Product Characteristics.
Infusion rates: Following dilution the DARZALEX infusion should be intravenously administered at the initial infusion rate presented in Table 6 as follows. Incremental escalation of the infusion rate should be considered only in the absence of infusion reactions. (See Table 6.)


Click on icon to see table/diagram/image


Management of infusion related reactions: Pre infusion medications should be administered to reduce the risk of infusion related reactions (IRRs) prior to treatment with DARZALEX.
For IRRs of any grade/severity, immediately interrupt the DARZALEX infusion and manage symptoms.
Management of IRRs may further require reduction in the rate of infusion, or treatment discontinuation of DARZALEX as outlined as follows (see PRECAUTIONS).
Grade 1-2 (mild to moderate): Once reaction symptoms resolve, the infusion should be resumed at no more than half the rate at which the IRR occurred. If the patient does not experience any further IRR symptoms, infusion rate escalation may be resumed at increments and intervals as clinically appropriate up to the maximum rate of 200 mL/hour (Table 6).
Grade 3 (severe): Once reaction symptoms resolve, restarting of the infusion may be considered at no more than half the rate at which the reaction occurred. If the patient does not experience additional symptoms, infusion rate escalation may be resumed at increments and intervals as appropriate (Table 6). The procedure previously mentioned should be repeated in the event of recurrence of Grade 3 symptoms. Permanently discontinue DARZALEX upon the third occurrence of a Grade 3 or greater infusion reaction.
Grade 4 (life threatening): Permanently discontinue DARZALEX treatment.
Missed dose(s):
If a planned dose of DARZALEX is missed, the dose should be administered as soon as possible and the dosing schedule should be adjusted accordingly, maintaining the treatment interval.
Dose modifications: No dose reductions of DARZALEX are recommended. Dose delay may be required to allow recovery of blood cell counts in the event of haematological toxicity (see PRECAUTIONS). For information concerning medicinal products given in combination with DARZALEX, see corresponding Summary of Product Characteristics.
Recommended concomitant medications: Pre-infusion medication: Pre-infusion medications should be administered to reduce the risk of IRRs to all patients 1-3 hours prior to every infusion of DARZALEX as follows: Corticosteroid (long-acting or intermediate-acting): Monotherapy: Methylprednisolone 100 mg, or equivalent, administered intravenously. Following the second infusion, the dose of corticosteroid may be reduced (oral or intravenous methylprednisolone 60 mg).
Combination therapy: Dexamethasone 20 mg, administered prior to every DARZALEX infusion (see PHARMACOLOGY: PHARMACODYNAMICS: PHARMACODYNAMIC PROPERTIES under ACTIONS).
Dexamethasone is given intravenously prior to the first DARZALEX infusion and oral administration may be considered prior to subsequent infusions.
Antipyretics (oral paracetamol 650 to 1,000 mg).
Antihistamine (oral or intravenous diphenhydramine 25 to 50 mg or equivalent).
Post-infusion medication: Post-infusion medications should be administered to reduce the risk of delayed infusion related reactions as follows: Monotherapy: Oral corticosteroid (20 mg methylprednisolone or equivalent dose of an intermediate acting or long acting corticosteroid in accordance with local standards) should be administered on each of the two days following all infusions (beginning the day after the infusion).
Combination therapy: Consider administering low-dose oral methylprednisolone (≤20 mg) or equivalent the day after the DARZALEX infusion. However, if a background regimen-specific corticosteroid (e.g. dexamethasone) is administered the day after the DARZALEX infusion, additional post-infusion medications may not be needed (see PHARMACOLOGY: PHARMACODYNAMICS: PHARMACODYNAMIC PROPERTIES under ACTIONS).
Additionally, for patients with a history of chronic obstructive pulmonary disease, the use of post-infusion medications including short and long acting bronchodilators, and inhaled corticosteroids should be considered. Following the first four infusions, if the patient experiences no major IRRs, these inhaled post-infusion 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: 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.
Based on population PK analyses, no dosage adjustments are necessary for patients with hepatic impairment (see PHARMACOLOGY: PHARMACOKINETICS under ACTIONS).
Elderly:
No dose adjustments are considered necessary (see PHARMACOLOGY: PHARMACOKINETICS under ACTIONS).
Paediatric population: The safety and efficacy of DARZALEX in children aged below 18 years of age have not been established.
No data are available (see PHARMACOLOGY: PHARMACODYNAMICS: PHARMACODYNAMIC PROPERTIES under ACTIONS).
Method of administration: DARZALEX is for intravenous use. It is administered as an intravenous infusion following dilution with sodium chloride 9 mg/mL (0.9%) solution for injection. For instructions on dilution of the medicinal product before administration, see Special precautions for disposal and other handling under CAUTIONS FOR USAGE.
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