Bortesun: Dosages and Ingredients | Full Prescribing Info

Concise Prescribing Info Full Prescribing Info Contents Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Adverse Reactions Drug Interactions MIMS Class ATC Classification Thai FDA Category Presentation/Packing Local Product Insert

Full Prescribing Info

Contents

Bortezomib.

Indications/Uses

Treatment of adult patients with multiple myeloma.
Treatment of adult patients with mantle cell lymphoma.

Dosage/Direction for Use

For subcutaneous or intravenous use only. Each route of administration has a different reconstituted concentration. Exercise caution when calculating the volume to be administered.
The recommended starting dose of BORTESUN is 1.3 mg/m² administered either as a 3 to 5 second bolus intravenous injection or subcutaneous injection.
Retreatment for Multiple Myeloma: May retreat starting at the last tolerated dose.
Hepatic Impairment: Use a lower starting dose for patients with moderate or severe hepatic impairment.
Dose must be individualized to prevent overdose.

Contraindications

Patients with hypersensitivity (not including local reactions) to bortezomib or mannitol.
Contraindicated for intrathecal administration.

Special Precautions

Peripheral Neuropathy: Manage with dose modification or discontinuation. Patients with pre-existing severe neuropathy should be treated with BORTESUN only after careful risk-benefit assessment.
Hypotension: Use caution when treating patients taking anti-hypertensives, with a history of syncope, or with dehydration.

Adverse Reactions

Most commonly reported adverse reactions (incidence ≥20%) in clinical studies include nausea, diarrhea, thrombocytopenia, neutropenia, peripheral neuropathy, fatigue, neuralgia, anemia, leukopenia, constipation, vomiting, lymphopenia, rash, pyrexia, and anorexia.

View ADR Reporting Link

Drug Interactions

Strong CYP3A4 Inhibitors: Closely monitor patients with concomitant use.
Strong CYP3A4 Inducers: Avoid concomitant use.

MIMS Class

Targeted Cancer Therapy

ATC Classification

L01XG01 - bortezomib ; Belongs to the class of proteasome inhibitors. Used in the treatment of cancer.

Thai FDA Category

Presentation/Packing

Form

Bortesun powd for inj 3.5 mg

Packing/Price

1's

Bortesun

bortezomib

Manufacturer:

Sun Pharma

Distributor:

DKLL

Marketer:

Ranbaxy