Bonspri Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage Patient Counseling Information MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Ofatumumab

Indications/Uses

Relapsing forms of multiple sclerosis (RMS) including relapsing-remitting disease & active secondary progressive disease in adults.

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Dosage/Direction for Use

SC Initially 20 mg inj at wk 0, 1 & 2 followed by subsequent 20 mg inj once mthly starting at wk 4.

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Overdosage

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Contraindications

Active HBV infection.

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Special Precautions

Discontinue use if progressive multifocal leukoencephalopathy is confirmed; serious opportunistic or recurrent infections develops in patients w/ low Ig; prolonged hypogammaglobulinemia requiring treatment w/ IVIg. Not to be inj into moles, scars, stretch marks, tender, bruised, red, scaly or hard skin. Increased risk of infection; HBV reactivation & infection; inj-related reactions. Perform HBV screening including HBsAg, hepatitis B core Ab & quantitative serum Ig prior to therapy. Immunogenicity. Not recommended w/ live or live-attenuated vaccines. Concomitant use w/ immunosuppressive therapy. Women of childbearing potential should use effective contraception during & at least 6 mth after last dose. Pregnancy & lactation. Childn.

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Use In Pregnancy & Lactation

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Adverse Reactions

URTI, systemic inj-related reactions, headache, local inj site reactions, UTI, back pain, decreased blood IgM.

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Drug Interactions

Increased risk of infection w/ immunosuppressant drugs including systemic corticosteroids. Additive immune system effects w/ immunosuppressive therapies.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Bonspri detailed prescribing information

Storage

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Description

View Bonspri description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Immunosuppressants

ATC Classification

L04AG12 - ofatumumab ; Belongs to the class of monoclonal antibodies. Used as immunosuppressants.

Regulatory Classification

Patient Counseling Information

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Presentation/Packing

Form

Bonspri soln for inj (pre-filled syringe) 20 mg/0.4 mL

Packing/Price

1's

Bonspri

ofatumumab

Manufacturer:

Novartis

Distributor:

DKSH