Medicinal Products

BICNU 100 mg / 3 mL

Generic drug of the therapeutic class: Oncology and Hematology
Active ingredients: Carmustine
laboratory: Emcure Pharma UK Ltd

Powder and solvent for solution for IV infusion
Box of 1 bottle of powder + 3 ml solvent bottle
All forms

Indication

As a consequence of its properties, the treatment of tumors of the central nervous system is its preferred indication. Bicnu is used alone or in combination in the treatment of:

· Primary or secondary brain tumors,

· Multiple myelomas,

· Hodgkin's lymphoma,

· Non-Hodgkin's lymphoma,

· Melanomas.

Dosage BICNU 100 mg / 3 mL Powder and solvent for solution for infusion IV Box of 1 vial of powder + vial of solvent of 3 ml

Dosage

· In all modes of administration in monotherapy or multidrug therapy, the time between courses containing BICNU should not be less than 6 weeks.

· In most cases, BICNU is prescribed in multidrug therapy at an average dose of 150 mg / m 2 every 6 weeks.

· The product can be administered as monotherapy (primary brain tumors).

· The dosage in previously untreated subjects is 200 mg / m 2 IV every 6 weeks. This dose is usually prescribed in a single injection, but can be divided into 2 injections of 100 mg / m 2 administered for 2 consecutive days.

Administration mode

Dissolve the contents of the BICNU vial with 3 ml of sterile alcoholic solvent. Then dilute the resulting solution with 27 ml of pyrogen-free sterile water. Shake well. Each milliliter of the reconstituted solution contains 3.3 mg of BICNU in a 10% aqueous solution of ethanol and has a pH of between 5.6 and 6.

The solution, thus reconstituted, is clear and colorless. It should be further diluted with 9% isotonic saline or 5% isotonic glucose for IV infusion.

The solution thus prepared should be injected only IV, in the form of a slow infusion, lasting between 1 to 2 hours.

BICNU should be administered as a slow intravenous infusion (see Warnings and Precautions ).

Short-term infusions can lead to severe pain and burns at the injection site as well as intense redness of the skin and conjunctival suffusion occurring within 2 hours and for approximately 4 hours.

BICNU is a freeze-dried powder and does not contain a preservative: it will therefore be necessary to prepare the solution extemporaneously.

In case of extravasation, the administration will be interrupted immediately.

Note: BICNU having a melting point of 30.5 ° C to 32 ° C, any exposure to a higher temperature results in liquefying; this is manifested by the presence of an oily film in the bottom of the bottle, a sign of decomposition that will rule out its use.

Handling modalities

The preparation of injectable cytotoxic solutions must be carried out by specialized and trained personnel with knowledge of the drugs used, under conditions ensuring the protection of the environment and especially the protection of the personnel handling. It requires a preparation room reserved for this purpose. It is forbidden to smoke, eat, drink in this room. Manipulators must have a set of equipment suitable for handling, including long-sleeved gowns, face masks, hood, safety goggles, sterile disposable gloves, worktop protection fields, containers and collection bags. waste. Excreta and vomit must be handled with care. Pregnant women should be warned and avoid manipulation of cytotoxics. Any broken container must be treated with the same precautions and considered as contaminated waste. Disposal of contaminated waste is by incineration in rigid containers labeled for this purpose.

These provisions may be envisaged within the framework of the oncology network (circular DGS / DH / 98 N ° 98/188 of 24 March 1998) in collaboration with any suitable and qualified structure.

Against indications

Do not administer to people who have ever been hypersensitive to Bicnu, nor to those who have had a reduction in the number of platelets, leukocytes or erythrocytes in previous chemotherapy or for other causes (see section 4.4). employment ).

· Child under 5 years old.

· Pregnancy and lactation (see section Pregnancy and breast-feeding ).

· In combination with yellow fever vaccine (see also section Interactions with other medicinal products and other forms of interaction ).

Side effects Bicnu

Hematological disorders mainly:

Delayed haematological toxicity characterized by thrombocytopenia and leukopenia occurring 4 to 5 weeks and 5 to 6 weeks after injection, respectively. Thrombocytopenia is usually more severe than leukopenia. Anemia can also occur but is usually less severe. This toxicity is dose-dependent and may become cumulative when treatments are repeated.

The occurrence of acute leukemias or spinal dysplasias has been reported in patients receiving long-term treatment.

Gastrointestinal disorders:

Frequently observed within 2 hours of injection: nausea and vomiting lasting up to 4 to 6 hours, being dose-dependent and requiring the use of antiemetics.

Respiratory disorders:

Carmustine-induced lung toxicity has been reported with up to 30% frequency. Early manifestations generally occur within 3 years of treatment and are characterized by infiltrates and / or pulmonary fibrosis; fatal cases have been reported. Cases of delayed pulmonary fibrosis occurring up to 17 years after treatment have also been reported.

These disorders occur regardless of the age of the patients.

Pulmonary toxicity is dose-dependent, with cumulative total doses between 1200 and 1500 mg / m 2 associated with an increased risk of pulmonary fibrosis.

Risk factors include smoking, existence of respiratory disease, pre-existing radiological abnormalities, sequential or concomitant thoracic irradiation, and association with other factors leading to pulmonary disorders.

Patients with a vital capacity or a carbon monoxide diffusion capacity 70% lower than the theoretical values ​​are particularly at risk.

Special pulmonary monitoring may be considered.

Hepatic disorders:

When administering high doses of BICNU, rare transient elevations of transaminases, alkaline phosphatases and bilirubin.

Renal disorders:

Renal impairment (decreased renal volume, azotemia, renal failure) after high and prolonged doses. These alterations have also been noted in patients receiving lower doses.

Cardiovascular disorders:

· Hypotension, tachycardia.

Also noted:

· Burns on the venous route.

· Rapid infusions can cause intense redness of the skin and suffusion of the conjunctiva within 2 hours and for about 4 hours.

· Amenorrhea, azoospermia.

· Some cases of neuroretinitis, chest pain, headache, allergic reactions have been reported.

· Injection site reaction:

Local soft tissue toxicity following extravasation of BICNU has been reported. Infiltration of BICNU may result in swelling, pain, erythema, burning sensation and exceptionally necrosis of the skin.

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