RIBOMUSTIN

What it is

RIBOMUSTIN contains bendamustine hydrochloride, an alkylating drug, as the active ingredient. It is a powder for injection, for intravenous infusion. RIBOMUSTIN is available in two strengths: 25 mg and 100 mg vials of bendamustine hydrochloride. It is administered by intravenous infusion after reconstitution with water for injection and further dilution with physiological saline (0.9%).

Approved indications

— First-line treatment of chronic lymphocytic leukaemia (Binet stage B or C). — Previously untreated indolent CD20-positive, stage III–IV Non-Hodgkin's lymphoma, in combination with rituximab. — Previously untreated CD20-positive, stage III–IV Mantle Cell Lymphoma in combination with rituximab, in patients ineligible for autologous stem cell transplantation. — Relapsed/Refractory indolent Non-Hodgkin's lymphoma.

Dosing overview

The solution is administered by intravenous infusion over 30–60 minutes.

Key safety warnings

Patients treated with RIBOMUSTIN may experience bone marrow failure. In the event of treatment-related myelosuppression, leukocytes, platelets, haemoglobin, and neutrophils must be monitored at least weekly. Treatment-related myelosuppression may require dose adjustment and/or dose delays. Bendamustine may cause prolonged lymphocytopenia (< 0.6 × 10⁹/L) and low CD4-positive T-cell counts (< 0.2 × 10⁹/L) for at least 7–9 months after completion of treatment, with more pronounced effects when combined with rituximab. Serious and fatal infections, including fatal sepsis, have occurred with bendamustine treatment. These infections included bacterial pneumonia and opportunistic infections such as Pneumocystis Jirovecii Pneumonia, Varicella Zoster Virus, Cytomegalovirus, and progressive multifocal leukoencephalopathy. Cases of progressive multifocal leukoencephalopathy including fatal cases have been reported following the use of bendamustine mainly in combination with rituximab or Obinutuzumab. In case of low CD4-positive T-cell counts (< 0.2 × 10⁹/L) Pneumocystis jirovecii pneumonia prophylaxis should be considered. Reactivation of hepatitis B in patients who are chronic carriers has occurred after treatment with bendamustine, with some cases resulting in acute hepatic failure or fatal outcome. Patients should be tested for HBV infection before initiating treatment, and for those with hepatitis B serology indicative of prior infection, a liver disease expert should be consulted before treatment starts. Skin reactions have been reported, including rash, severe cutaneous reactions and bullous exanthema. Cases of Stevens–Johnson syndrome and Toxic Epidermal Necrolysis, some fatal, have also been reported. Some cases of these severe skin reactions occurred when bendamustine was administered concomitantly with allopurinol or with other anticancer agents. Cases of drug reaction with eosinophilia and systemic symptoms have been reported with bendamustine in combination with rituximab. Fatal cases of myocardial infarction and cardiac failure have been reported with bendamustine treatment. Patients with concurrent or history of cardiac disease should be observed closely.

Contraindications

RIBOMUSTIN is contraindicated in patients with hypersensitivity to the active substance or excipients, severe hepatic impairment (serum bilirubin > 3.0 mg/dL), jaundice, severe bone marrow suppression and severe blood count alteration (leukocyte and/or platelet values < 3 × 10⁹/L or < 75 × 10⁹/L respectively), major surgery less than 30 days before treatment starts, infections (especially involving leukocytopaenia), yellow fever vaccination, and during breast-feeding.

PBS listing

RIBOMUSTIN bendamustine hydrochloride is registered on the ARTG in two strengths: 25 mg and 100 mg powder for injection vials, both first listed on 30 June 2014. Specific PBS listing details regarding restriction type and ex-manufacturer price are not provided in the available source documents.

Regulatory history

RIBOMUSTIN bendamustine hydrochloride 25 mg and 100 mg powder for injection vials were first registered on the Australian Register of Therapeutic Goods on 30 June 2014.