

Biobin 100mg/1ml Injection (Cytarabine)
Manufactured By
Zydus
Pack Of
1
Salt Composition
Cytarabine
Storage
Controlled room temperature
ALL SUBSTITUTES
Overview
Biobin 100gm/1ml injection contains cytarabine (cytosine arabinoside), an antimetabolite chemotherapy medicine used in acute myeloid leukemia (AML) treatment. It is also used in acute lymphoblastic leukemia and selected lymphoma regimens and, in preservative-free formulations.
Cytarabine injection can be administered intrathecally for meningeal leukemia. However, the medicine works by converting inside cells to an active triphosphate that blocks DNA synthesis. Therefore, the 1 g vial/10 mL strength is not a standard patient dose: conventional and high-dose regimens differ by more than ten-fold and are calculated in mg/m². Hence, patients are advised to use the medication only under medical supervision for safe and effective treatment.
Quick Product Facts
| Field | Publication wording |
|---|---|
| Brand | Biobin 100gm/1ml Injection |
| Molecule / Combination | Cytarabine |
| Strength / Composition | 100 gm/1 mL |
| Dosage form | Injection |
| Manufacturer / Marketer | Zydus |
| Pack / Presentation | 1 vial |
| Storage | Controlled room temperature |
| Prescription | Required |
Uses and Indications
Uses of Cytarabine Injection include:
- Acute Myeloid Leukemia (AML)
- Acute Lymphoblastic Leukemia (ALL)
- Some aggressive lymphomas
The medicine is essential for AML treatment and, particularly, for its induction and consolidation phases. Induction usually involves continuous infusion of cytarabine 100gm/1ml injection along with anthracyclines under the "7+3" protocol, whereas consolidation and salvage therapy usually use high-dose cytarabine 100gm/1ml. The injection without preservatives can also be given by the intrathecal route for prophylaxis or treatment of leukaemia meningeal involvement. Careful consideration of the route, dose, and formulation of the medicine is necessary since cytarabine injection preparations with preservatives should not be administered intrathecally.
How Biobin 100mg/1ml Injection Works
The drug Biobin 100gm/1ml Injection is converted into its active form, known as cytarabine triphosphate (ara-CTP), within the cell. The ara-CTP inhibits the nucleotides required for the synthesis of DNA as well as DNA polymerase, which is essential for DNA synthesis. Consequently, the cancer cells lack the ability to synthesize DNA and reproduce normally. However, the mode of action of cytarabine 100gm/1ml injection is selective for cells that synthesize DNA.
Clinical Evidence for Biobin 100mg/1ml Injection
7+3 AML induction: Over many years, scientific research has proved that the combination of Biobin 100gm/1ml injection with an anthracycline has become a standard way of treating AML.
High-dose cytarabine consolidation: Clinical studies have demonstrated the effectiveness of using high doses of cytarabine injection in decreasing the likelihood of recurrence of AML, especially in young and healthy patients.
Side Effects of Biobin 100mg/1ml Injection
Just like any other medication, Biobin 100gm/1ml injection is also associated with some side effects. Most of the side effects are minor and usually go away within some time.
Common side effects
- Low blood counts
- Fever/infection
- Nausea/vomiting
- Mouth sores
- Rash
- Diarrhea
- Liver enzyme elevations
Serious side effects
- Severe myelosuppression/sepsis
- Cerebellar neurotoxicity at high doses
- Severe conjunctivitis/keratitis
- Pulmonary toxicity
- Cytarabine syndrome
- Gastrointestinal ulceration/necrosis
Critical Safety Warning
HIGH-DOSE NEUROTOXICITY: High-dose Biobin 100gm/1ml Injection may also cause central nervous system toxicity, which is particularly common among older patients and those with kidney impairment. This is characterized by confusion, speech difficulties, loss of coordination, and seizures. Before administering each high-dose regimen, patients are normally subjected to neurological evaluation to identify any neurological effects. Therefore, eye drops with steroids may also be used when administering high doses.
Biobin 100mg/1ml Injection Dosage and How To Take It
Important: Dose and regimen must be prescribed by the treating specialist. Tablet/vial strength is not necessarily the patient dose. Do not start, stop, split, combine, or substitute treatment based on website information.
| Clinical situation | Dose |
|---|---|
| AML induction example | 100–200 mg/m²/day by continuous IV infusion for 7 days in classic induction regimens. The anthracycline is given separately. |
| High-dose consolidation | Often 1–3 g/m² IV every 12 hours on specific days, depending on the treatment protocol. |
| Intrathecal use | Only cytarabine 100gm/1ml injection without any preservatives must be administered intrathecally. The dosage is determined by an expert according to the protocol. |
| Renal/hepatic impairment | It may lead to severe side effects; thus, the dosage has to be adjusted, or in some cases, even the therapy may not be recommended. |
Biobin 100mg/1ml Injection Missed Dose
If a chemotherapy dose is delayed, contact the hematology/oncology department to ensure the correct schedule of the medication after missing it. Do not self-reschedule. High-dose and intrathecal schedules are protocol-specific, and missing a dose may require the entire cycle to be re-planned.
Safety Advice for Biobin 100mg/1ml Injection
| Category | Status | Guidance |
|---|---|---|
| Pregnancy | Avoid | Cytarabine Injection can harm an unborn baby. Tell the doctor if you are pregnant or planning pregnancy. |
| Breastfeeding | Avoid | Breastfeeding is generally not recommended during treatment. |
| Neurologic | High priority | High-dose cytarabine 100gm/1ml injection may cause problems with coordination, speech, or mental alertness, and thus neurological examinations are crucial. |
| Eyes | Preventive care | High-dose cytarabine injection is usually done along with steroid eye drops to alleviate irritation and inflammation of the eyes. |
| Infection | Urgent review | Having a fever in the presence of low white blood cells is an emergency situation and requires urgent medical treatment. |
Monitoring During Biobin 100mg/1ml Injection Treatment
- Blood tests are frequently performed in order to assess red blood cells, white blood cells, and platelets.
- The functioning of the kidneys and liver is assessed to ensure that the patient's body can tolerate the therapy.
- With a high-dose cytarabine 100gm/1ml injection, the signs of confusion, impaired coordination, speech difficulties, and any other neurological symptoms are assessed.
- Eye symptoms, such as redness, pain, irritation, and blurred vision, are assessed.
- The temperature and signs of infection are assessed, particularly if there are low levels of white blood cells.
- If there are high levels of cancer cells in the patient, tests can be performed to assess the risk of developing tumor lysis syndrome.
Biobin 100mg/1ml Injection Fact Box
| Parameter | Verified / publication wording |
|---|---|
| Brand | Biobin 100gm/1ml Injection |
| Generic / Combination | Cytarabine |
| Strength | 100 gm/1 mL |
| Form | Injection |
| Manufacturer / Marketer | Zydus |
| Pack | 1 vial |
| Storage | Controlled room temperature |
| Major safety theme | HIGH-DOSE NEUROTOXICITY |
| Prescription | Yes |
Biobin 100mg/1ml Injection Drug Interactions
| Drug / Class | Risk | What To Do |
|---|---|---|
| Other myelosuppressive chemotherapy | Additive cytopenias | Blood tests need to be conducted as recommended in the treatment process. |
| Digoxin | Absorption/effect may be reduced in some settings. | The doctor will observe the effectiveness of the treatment if required. |
| Gentamicin | In vitro antagonism reported; clinical relevance uncertain | Use only after specialist review. |
| Live vaccines | Infection risk | Live vaccines are not recommended when the immune system is compromised. |
FAQs About Biobin 100mg/1ml Injection
Is 100 gm of cytarabine injection the same as the patient dose?
No. The Biobin injection dose depends on the body surface area of the patient as well as the treatment regimen. There may be great variation between low-dose and high-dose regimens.
Why are eye drops used with a cytarabine 100gm/1ml injection?
Since high-dose cytarabine 100gm/1ml injection may cause irritation and inflammation of the eyes, however, steroid eye drops may be prescribed.
Why do patients need coordination testing for high-dose cytarabine injection?
High-dose cytarabine 100gm/1ml Injection may affect the cerebellum, which regulates coordination. Coordination testing includes walking, coordination, speech, and other neurological functions.
Can the same vial of cytarabine injection be administered intrathecally?
Not always. The preservative-free form of cytarabine 100gm/1ml injection that is safe to use intrathecally should be used.
What does the 7 + 3 cytarabine 100gm/1ml injection regimen mean?
It is an old standard of care for patients with acute myeloid leukemia in which cytarabine injection is given for 7 days and in combination with an anthracycline for 3 days.
What should one do when having a fever while being treated with a cytarabine 100gm/1ml Injection?
Call a doctor immediately, as the patient will have decreased white blood cells that could predispose them to infection.
References
- Current cytarabine injection prescribing information https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/071868s032lbl.pdf
- Current AML guidelines (NCCN/ELN) for induction and consolidation https://jnccn.org/view/journals/jnccn/24/6/article-p222.xml?print
- Landmark AML cytarabine dose/intensity studies https://pubmed.ncbi.nlm.nih.gov/38861379/
Marketer Details
Zydus
Disclaimer
Globanspharma main goal is to ensure that its consumers get correct, authentic, and reliable information that has been examined by medical professionals. This website's content has only been created for informational purposes. However, this is not meant to replace the medical advice and treatment given by a qualified physician. The information presented herein may not cover everything about particular lab tests, medicines, and health conditions, all possible side effects, and warnings. Please discuss all your queries related to any medication and illness with your doctor. We intend to support and maintain the doctor-patient relationship, not to substitute it or take its place.








