Rozanolixizumab Dosage

Medically reviewed by Drugs.com. Last updated on Dec 15, 2023.

Usual Adult Dose for Myasthenia Gravis

Body-weight-based dosing as a subcutaneous infusion once weekly:

• Less than 50 kg: 420 mg (3 mL)
• 50 kg to less than 100 kg: 560 mg (4 mL)
• 100 kg and above: 840 mg (6 mL)

Duration of treatment cycle: 6 weeks

Comments:

• Administer the prescribed dose of this medication as a subcutaneous infusion using an infusion pump set at a rate of up to 20 mL per hour.
• The decision to proceed with additional treatment cycles should be based on clinical assessment. The safety of initiating subsequent cycles within a period shorter than 63 days from the beginning of the previous treatment cycle has not been confirmed.

Use: For the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug should be administered subcutaneously by a healthcare provider using an infusion pump.
• This drug does not contain preservatives and each vial is for single use only, any remaining product should be discarded.
• Infusions should not be given into areas where the skin is tender, erythematous, or indurated. The preferred site for administration is in the lower right or lower left part of the abdomen, below the belly button.
• If a scheduled dose is missed, this drug may be administered within 4 days of the scheduled time. Following this, the original dosing schedule should be resumed until the completion of the treatment cycle.

Reconstitution/preparation techniques:

• This drug should only be prepared and infused by a healthcare provider.
• Refer to manufacturer product information for detailed information on preparation and administration.

Storage requirements:

• Store at 36F to 46F (2C to 8C) in the original carton.
• Protect from light until the time of use.
• Do not freeze. Do not shake.
• If necessary, vials can be kept at room temperature, up to 77F (25C), for a maximum period of 20 days while stored in their original carton to shield them from light.
• Once a vial has been stored at room temperature, it should not be returned to the refrigerator.
• The vial should be discarded 20 days after it has been removed from the refrigerator.
• Write the discard date in the designated space on the carton. If the vial is not used within 20 days or if the expiration date has passed before that, discard it.

General:

• This drug causes transient reduction in IgG levels, and immunization with live-attenuated or live vaccines is not recommended during treatment. Evaluate the need to administer age-appropriate immunizations according to immunization guidelines before initiation of treatment.
• There is limited safety and efficacy data in patients 65 years of age and older to determine whether they respond differently from younger adult patients.
• Healthcare professionals are asked to report any suspected adverse reactions to UCB, Inc. at 1-844-599-2273 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Monitoring:

• For signs and symptoms of hypersensitivity reactions
• For clinical signs and symptoms of infections

Patient advice:

• Read the Patient Information and Instructions for Use (if available).
• Patients should inform their healthcare provider about any history of infections and promptly notify their healthcare provider if they experience any symptoms of an infection.
• Patients should ensure they receive age-appropriate vaccines based on immunization guidelines before starting a new treatment cycle with this drug.
• It is not recommended to receive live or live-attenuated vaccines while undergoing treatment with this drug.
• Patients should be aware that this drug has the potential to cause aseptic meningitis. If they develop symptoms consistent with meningitis, they should contact their healthcare provider.
• Patients should be informed about the signs and symptoms of hypersensitivity reactions. They should immediately contact their healthcare provider if they experience any signs or symptoms of hypersensitivity reactions.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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