Bortezomib for Injection Bortenat- 3.5Mg

Bortezomib for Injection Bortenat- 3.5Mg

Bortenat 3.5mg injection is used for treating some particular types of cancers such as multiple myeloma and mantle cell lymphoma. This is an antineoplastic drug, therefore it is used in chemotherapy. The drug works by blocking the function of some types of protein that is present in the cancer cell, which ultimately destroys it. The active ingredient in Bortenat is Bortezomib. This 3.5 mg injection has been manufactured by Natco Pharma Ltd. And is available at galaxysuperspeciality in countries like USA, Russia, China, Peru and Romania.

Indication for use of Bortezomib Injection:

Bortezomib for Injection Bortenat- 3.5Mg is indicated for the treatment of the patients with:

• Multiple Myeloma
• Mantle Cell Lymphoma
• Patients with Mantle Cell Lymphoma who have received at least 1 prior therapy

Uses of Bortenat- 3.5Mg Injection:

This medication is a chemotherapy drug for cancer that is used for treating some types of tumours. It works by blockings certain proteins which help in slowing down the growth and the spread of cancer within the body. It is used in case of the following types of cancer:

• Mantle Cell Lymphoma
• Multiple Myeloma (a cancer of the bone)

Bortenat is available at Galaxysuperspeciality a leading trader supplier of medicines.

Dosage for Bortenat- 3.5Mg Injection

Bortenat is administered as a 3- 5 sec bolus IV injection in a combination with oral melphalan and oral pednisone for nine cycles of 6- week treatment to previously untreated Multiple Myeloma.

In the cycles of 1- 4 of Bortenat is administered twice weekly (on days 1, 4, 8, 11, 22, 25, 29 and 32). In the cycles of 5- 9 of Bortenat is administered once weekly (on days 1, 8, 22 and 29).

Bortenat 3.5 mg injection is administered in the form of a 3- 5 sec IV bolus injection through a peripheral or central IV catheter which is further followed by a flush with 0.9% of sodium chloride solution for the injection.

Note: There needs to be at least 72 hours gap between the consecutive doses of Bortenat.

Contraindications of Bortenat 3.5Mg Injection:

The following are the contradictions of Bortenat 3.5mg injection:

• Pregnancy:

Do not use Bortenat if you are pregnant as it is known to cause harm to the unborn child.

• Blood Cells:

Bortenat can reduce the count of blood cells in the body which help your body in fighting infections and helping your blood clot faster. Due to this contradiction it is advised to get your blood tested on a frequent basis. These can also determine the course of your cancer treatments which can be delayed based on the results of these tests.

• Psychological and Physiological Impact:

It is possible to experience a gradual change in the mental state or one can also experience decreased vision, speech and walking difficulties, impaired thinking or reactions. It is advised to inform the doctor for immediate medical attention.

• Dehydration:

There can be a possibility of becoming dehydrated if you experience vomiting or diarrhoea with Bortenat, therefore it is advised to stay hydrated.

• Renal Impairment/ Impaired Vision:

This medication can cause blurred vision; therefore it is suggested to be careful while driving or doing anything that requires alertness and clarity of sight. Also, the pharmacokinetics of Bortenat is not influenced by the degree of renal impairment. Thus, adjustment of doses of Bortenat 3.5 mg injection is not necessary for patients having renal insufficiency.

• Dialysis:

As the dialysis can reduce the concentration levels of Bortenat, the drug should be administered after the procedure of dialysis has been done.

• Hepatic Impairment:

Patients who experience mild hepatic impairment need not require any adjustment for the starting dose and must be treated with the recommended Bortenat dose. Patients having a moderate or severe hepatic impairment should be started with Bortenat at a reduced dose of 0.7 mg/m2/ injection during the 1^st cycle of the treatment and a subsequent advancement to 1mg/ m2, or a further reduction of 0.5mg/ m2 which may be regulated as per the tolerance of the patient.

• Children aged 2- 16 years:

The safety and effectiveness of Bortenat 3.5 mg injection has not been established in children.

Instructions for the Use of 3.5Mg Injection:

• This medication is administered through an injection into a vein or under the skin by a medical professional or doctor. If medication is administered under the skin, ensure that the site of the injection is changed each time to reduce the injury that gets caused under the skin.
• The dosage that is administered to the patients is based on the body size, the medical condition and history, and the response to therapy.
• It is suggested to drink plenty of fluids while being treated with Bortenat 3.5mg injection for preventing dehydration.
• It is advised to read the Patient Information Leaflet provided in the packaging and to consult your doctor or pharmacist if there is any difficulty.

Note: The above discussed instructions are intended to familiarize the patients with the effect of the drug and are not recommended for self- treatment.

Side Effects:

• Dizziness
• Light headedness
• Tiredness
• Nausea
• Diarrhoea
• Constipation
• Vomiting
• Loss of appetite
• Weakness
• Blurred vision
• Pain or redness at injection site

Some Less Serious Side effects are:

• Reduced ability of the body to fight infection. Inform your doctor immediately if you develop any signs of infections such as fever, chills, or persistent sore throat.

Some Side effects are:

• Easy bruising or bleeding
• Peripheral Neuropathy (tingling, numbness, pain, burning feeling of the hands or feet)
• Fainting
• Pain in the stomach
• Black stools
• Coffee- ground vomit
• Trouble in breathing
• Swelling or Pain in the lower legs
• Fast or irregular heartbeat
• Severe headache
• Vision problems
• Mood changes (such as rarely having thoughts of suicide)
• Swelling of the hands, ankles or feet
• Changes in the amount of urine
• Yellowing or pale skin or eyes
•  Dark urine.

Very serious side effects are:

• Chest pain
• Weakness on one side of the body
• Slurred speech
• Seizures

An allergic reaction to this drug is very unlikely, but if one occurs, then it is advised to get immediate medical help. Symptoms of Allergic Reactions:

• Rash,
• Itching or swelling (especially of the face/tongue/throat)
• Severe dizziness
• Trouble breathing

Note: This is not a complete list of possible side effects. If any of the above mentioned side effects persist or worsen, inform your doctor immediately. Remember this medication has been prescribed to you by the doctor as he or she has judged that the benefit of the drug to you is greater than the risk of the side effects.

Precautions:

• Before using this medication inform your doctor if you are allergic to the drug or have any other allergies. The product may contain some inactive ingredients like boron, mannitol that can lead to other allergic reactions or related problems.
• Inquire more details from the doctor before you start with this treatment, for your safety and avoiding any unknown reactions.
• Before using this drug, provide your medical history to the doctor especially in case of:

–          Nerve sensation problems (e.g., peripheral neuropathy)

–          Heart diseases

–          Low blood pressure

–          loss of body fluids (dehydration)

–          diabetes

–          liver disease

–           severe kidney disease

–          certain viral infection (herpes, shingles)

• For minimizing the effect of dizziness and light headedness, get up slowly when seated or in a lying position. This drug may make you dizzy or lead to visionary changes. Avoid driving, using machinery, or doing any activity which requires alertness or clarity of vision until you are able to perform such activities safely.
• Limit the consumptions of alcoholic beverages.
• Do not get immunizations or vaccinations without the consent of your doctor; also avoid contact with people who have recently received an oral polio vaccine.
• Be cautious around sharp objects like safety razors or nail cutters and avoid activities like contact sports for lowering the chance of getting cut, bruised or injured.
• Wash your hands properly for preventing the spread of infections.
• In case you become pregnant or plan to become pregnant, inform your doctor immediately. Use reliable forms of birth control contraceptives during the treatment with this drug.
• It is not known if Bortenat passes into the breast milk. Breast feeding is not recommended during the use of this drug because of the potential risk to the nursing infant.