Biceltis 440mg (Injection)

Manufacturer: Cipla Ltd

Salt Composition : Trastuzumab(440mg)


Biceltis 440mg Injection is given as an injection by a qualified medical professional. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too much can cause very serious side effects. It may take several weeks or months for you to see or feel the benefits but do not stop taking it unless your doctor tells you to.



Basic Information

Mechanism Of Action

Biceltis 440mg Injection is used in the treatment of breast and stomach cancer. It works by killing the cancer cells by inhibiting HER2 (human epidermal growth factor receptor protein).

Pharmacokinets

Trastuzumab pharmacokinetics are characterized by a low systemic clearance, a low volume of distribution (4l) and a very long half-life (28 days) comparable to that of endogenous immunoglobulins G. The elimination pathways are not yet defined and the clinical relevance of trastuzumab kinetic variability is unknown.

Side Effects

Most side effects do not require any medical attention and disappear as your body adjusts to the medicine. Consult your doctor if they persist or if you’re worried about them

Common side effects of Biceltis

Anemia (low number of red blood cells)

Chills

Common cold

Cough

Decreased blood cells (red cells, white cells, and platelets)

Diarrhea

Fatigue

Fever

Headache

Heart failure

Infection

Insomnia (difficulty in sleeping)

Mucosal inflammation

Nausea

Rash

Stomatitis (Inflammation of the mouth)

Taste change

Upper respiratory tract infection

Weight loss

Contra Indications

Contraindications for trastuzumab treatment include a history of hypersensitivity to trastuzumab treatment or murine proteins, severe dyspnea at rest resulting from complications of advanced malignancy, and requiring supplementary oxygen therapy.

Pregnancy Related Information

Biceltis 440mg Injection is unsafe to use during pregnancy as there is definite evidence of risk to the developing baby. However, the doctor may rarely prescribe it in some life-threatening situations if the benefits are more than the potential risks. Please consult your doctor.


Product And Alcohol Interaction

Biceltis 440mg Injection may cause excessive drowsiness with alcohol.


Breast Feeding Related Information

Biceltis 440mg Injection is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.


Children Related Information

Use with caution Below 9years: Contraindicated

Indications

As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.

Interactions

Abraxane (paclitaxel protein-bound)

Acetylsalicylic Acid (aspirin)

Adriamycin (doxorubicin)

Benadryl (diphenhydramine)

Calcium, Magnesium and Zinc (multivitamin with minerals)

Cymbalta (duloxetine)

Ethyl Alcohol (ethanol)

Nexium (esomeprazole)

Typical Dosage

Kindly do not self administer.

Storage Requirements

Store in a refrigerator (2 - 8°C). Do not freeze.


Effects Of Missed Dosage

If you miss a dose of Biceltis 440mg Injection, please consult your doctor.


Effects Of Overdose

Consult a doctor before taking any medicines.

Expert Advice

It is given as an injection into your vein or under the skin, usually over 1 hour.

Use effective contraception method to prevent pregnancy while taking this medicine and for 7 months after you stop the treatment.

Your doctor will monitor your heart regularly while taking this medicine. Inform your doctor if you notice symptoms such as breathlessness, cough, shivering, swelling of legs and arm.

Inform your doctor if you are pregnant, planning pregnancy or breastfeeding. 

How To Use

Your doctor or nurse will give you this medicine. Kindly do not self administer.


FAQs

Q. What are the serious side effects of Biceltis 440mg Injection?

There are various side effects related to Biceltis 440mg Injection such as sore throat, fever, chills, excessive tiredness, pale skin, nosebleeds, and other unusual bruising or bleeding. One can also experience stomach pain, seizures, hallucinations, muscle cramps, and spasms. Along with that, nausea or vomiting, loss of appetite, fatigue, rapid heart beat, discoloration of urine; decreased amount of urine, difficulty in urinating, pain when urinating, and other signs of infection can also be observed with the use of Biceltis 440mg Injection. You should call your doctor immediately if you notice any such symptoms.

Q. How long after Biceltis 440mg Injection therapy can I get pregnant?

Women of child-bearing age should use effective contraception during Biceltis 440mg Injection therapy and for 7 months after completing the treatment. You can plan your pregnancy after 7 months of treatment with Biceltis 440mg Injection.

Q. How long should Biceltis 440mg Injection be taken?

Patients with early breast cancer should take Biceltis 440mg Injection for 1 year or until disease recurs, whichever occurs first. It is not advised to extend the treatment beyond 1 year in patients of early breast cancer.

Q. Is fasting required before administering Biceltis 440mg Injection?

No, fasting is not required before administering Biceltis 440mg Injection. It should be given under the guidance of a doctor who is experienced in giving cancer chemotherapy and should be given only by a healthcare professional.

Q. How is Biceltis 440mg Injection given, intravenously or intramuscularly?

There are 2 different formulations available for administration of Biceltis 440mg Injection, one is given as an infusion into a vein (intravenous infusion) and the other is given as an injection under the skin (subcutaneous injection). It is important to check the product labels to ensure that the correct formulation is being given as prescribed. Biceltis 440mg Injection intravenous formulation is not for subcutaneous use and should be given as an intravenous infusion only. Your doctor may consider switching your Biceltis 440mg Injection intravenous treatment to Biceltis 440mg Injection subcutaneous treatment (and vice versa) if considered appropriate for you.

Q. Can Biceltis 440mg Injection be given to HER2 negative cancer patients?

No, Biceltis 440mg Injection cannot be given in patients with HER2 negative cancer cells. Biceltis 440mg Injection belongs to class of monoclonal antibody. It binds selectively to a protein called human epidermal growth factor receptor 2 (HER2). HER2 is found, in large amounts, on the surface of some cancer cells. When Biceltis 440mg Injection binds to HER2, it stops the growth and spread of the cancer cells. Therefore, it is only effective in HER2 positive patients (in which HER2 is present) and will not be beneficial for HER2 negative patients (in which HER2 is not present).

Q. Why has my doctor advised for investigations of heart?

Biceltis 440mg Injection when used with anthracycline class of anti-cancer medicines (eg doxorubicin) may adversely affect your heart. Hence, your doctor needs to check the health of your heart initially before starting treatment and during treatment.

Q. How frequently heart investigations are required?

Heart investigations should be performed at the starting of the treatment. It should be repeated every 3 months during treatment and every 6 months after the discontinuation of treatment until 24 months from the last administration of Biceltis 440mg Injection. Those patients who already have heart-related problems will require investigations every 12 weeks.