Bonspri

Bonspri Dosage/Direction for Use

ofatumumab

Manufacturer:

Novartis

Distributor:

DKSH
Full Prescribing Info
Dosage/Direction for Use
Assessments Prior to First Dose of BONSPRI: Hepatitis B Virus Screening: Prior to initiating BONSPRI, perform Hepatitis B virus (HBV) screening. BONSPRI is contraindicated in patients with active HBV confirmed by positive results for Hepatitis B surface antigen [HBsAg] and anti-HBV tests. For patients who are negative for HBsAg and positive for Hepatitis B core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment with BONSPRI [see Infections under Precautions].
Serum Immunoglobulins: Prior to initiating BONSPRI, perform testing for quantitative serum immunoglobulins [see Reduction in Immunoglobulins under Precautions]. For patients with low serum immunoglobulins, consult immunology experts before initiating treatment with BONSPRI.
Vaccinations: Because vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation until B-cell repletion, administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of BONSPRI for live or live-attenuated vaccines, and whenever possible, at least 2 weeks prior to initiation of BONSPRI for inactivated vaccines [see Infections under Precautions].
Recommended Dosage: The recommended dosage of BONSPRI is: initial dosing of 20 mg by subcutaneous injection at Weeks 0, 1, and 2, followed by; subsequent dosing of 20 mg by subcutaneous injection once monthly starting at Week 4.
Missed Doses: If an injection of BONSPRI is missed, it should be administered as soon as possible without waiting until the next scheduled dose. Subsequent doses should be administered at the recommended intervals.
Administration Instructions: Administer by subcutaneous injection only.
BONSPRI is intended for patient self-administration by subcutaneous injection.
Administer BONSPRI in the abdomen, thigh, or outer upper arm subcutaneously. Do not give injection into moles, scars, stretch marks or areas where the skin is tender, bruised, red, scaly, or hard.
The first injection of BONSPRI should be performed under the guidance of a healthcare professional [see Injection-Related Reactions under Precautions].
BONSPRI syringes are for one-time use only and should be discarded after use. See Instructions for Use and Handling under Cautions for Usage for complete administration instructions.
Preparation of BONSPRI: The BONSPRI "Instructions for Use and Handling under Cautions for Usage" for each presentation contains more detailed instructions on the preparation of BONSPRI.
Before administration, remove BONSPRI pre-filled syringe from the refrigerator and allow BONSPRI to reach room temperature for about 15 to 30 minutes. DO NOT remove the needle cover while allowing the pre-filled syringe to reach room temperature.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the liquid contains visible particles or is cloudy.
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