Biotrexate 50mg/2ml Injection (Methotrexate)
Prescription RequiredManufactured By
Zydus
Pack Of
1
Salt Composition
Methotrexate
Storage
Below 30°C
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Overview
Biotrexate 50mg/2ml injection contains methotrexate 25 mg/mL, an antifolate medicine used at very different doses in cancer, autoimmune disease, and certain ectopic-pregnancy protocols. Methotrexate injection inhibits dihydrofolate reductase and other folate-dependent pathways, reducing DNA synthesis and immune-cell proliferation. The injection concentration must never be mistaken for the patient’s dose. Oncology regimens range from low/intermediate doses to high-dose methotrexate measured in g/m² with leucovorin rescue. Weekly low-dose methotrexate 50mg/2ml injection used in rheumatoid arthritis/psoriasis is fundamentally different from oncology dosing.
Quick Product Facts
| Field | Publication wording |
|---|---|
| Brand | Biotrexate |
| Molecule / Combination | Methotrexate |
| Strength / Composition | 50 mg/2 mL (25 mg/mL) |
| Dosage form | Injection |
| Manufacturer / Marketer | Zydus |
| Pack / Presentation | 1 vial |
| Storage | Below 30°C |
| Prescription | Required |
Uses and Indications
- Acute lymphoblastic leukemia (ALL)
- Certain lymphomas
- Osteosarcoma (bone cancer)
- Gestational trophoblastic neoplasia
- Breast and head-and-neck cancers
- Rheumatoid arthritis
- Severe psoriasis
- Central nervous system (CNS) cancer involvement or prevention in selected treatment
Methotrexate injection acts differently according to the disease and mode of treatment. It is administered through the intravenous route, by muscle injection, or by the subcutaneous route. In case of treatment involving the central nervous system, only the appropriate preservative-free form should be administered intrathecally. The high-dose medicine treatment requires leucovorin rescue, adequate fluid intake, alkalization of urine, and monitoring of methotrexate blood concentration.
How Biotrexate 50mg/2ml Injection Works
Methotrexate 50 mg/2 mL Injection is an inhibitor of an enzyme called dihydrofolate reductase (DHFR). It is responsible for the activation of folic acid in the body. This leads to a decrease in the amount of folic acid used by the body in the synthesis of deoxyribonucleic acid and other cell components. Cancer and immunomodulatory cells, which have rapid rates of division and growth, are affected more.
Clinical Evidence for Biotrexate 50mg/2ml Injection
ALL/lymphoma protocols: Biotrexate 50mg/2ml injection is a foundational component of pediatric/adult ALL and CNS-directed therapy.
Osteosarcoma high-dose therapy: High-dose methotrexate Injection with leucovorin rescue is an established component of curative multi-agent osteosarcoma therapy.
RA trials: Weekly low-dose methotrexate 50mg/2ml injection is the conventional anchor DMARD for rheumatoid arthritis.
Side Effects of Biotrexate 50mg/2ml Injection
The effects of the Biotrexate 50mg/2ml injection on various parts of the body are due to its interference with the division of rapidly growing cells. The side effects can be influenced by the dosage, duration of use, and route of administration.
Common side effects
- Mouth sores
- Nausea
- Fatigue
- Low blood counts
- Elevated liver enzymes
- Rash
Serious side effects
- Severe myelosuppression/sepsis
- Hepatotoxicity/fibrosis
- Pneumonitis
- Severe mucositis/GI ulceration
- Kidney failure and delayed clearance in high-dose therapy
- Neurotoxicity
- Fatal toxicity from daily instead of weekly dosing in non-oncology use
Critical Safety Warning
DOSING-ERROR WARNING: The administration of methotrexate injection is one aspect that has to be adhered to carefully since daily administration of weekly injection can lead to toxicity, which may be fatal. High doses of the medication for cancer therapy require adequate hydration, urine alkalinization, Biotrexate 50mg/2ml injection blood level monitoring, and leucovorin rescue therapy. For intrathecal treatment, the medicine formulation with no preservatives should be used.
Biotrexate 50mg/2ml 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 |
|---|---|
| Rheumatoid arthritis example | It is usually taken once a week, not every day. The doctor decides the dose and route. |
| High-dose oncology | High doses are administered in certain cancer treatments and require leucovorin rescue and careful monitoring. |
| Intrathecal | This treatment requires that only the preservative-free version of methotrexate 50mg/2ml injection suitable for intrathecal administration be utilized. |
| Renal impairment | Biotrexate 50mg/2ml injection is primarily excreted through the renal system. Impaired renal function leads to accumulation of the drug. |
Biotrexate 50mg/2ml Injection Missed Dose
For weekly low-dose therapy, if a dose is missed, contact the doctor rather than doubling. For oncology/high-dose or intrathecal therapy, contact the medical supervision immediately because schedule and rescue timing are critical.
Safety Advice for Biotrexate 50mg/2ml Injection
| Category | Status | Guidance |
|---|---|---|
| Pregnancy | Contraindicated for most indications | Methotrexate 50mg/2ml injection is potentially dangerous for the unborn child and can lead to termination of pregnancy. |
| Breastfeeding | Avoid | The drug can get into breast milk, which is why breastfeeding is usually not advisable while you are taking it. |
| Kidney | High priority | Methotrexate injection is mostly excreted by the kidneys. Kidney impairment can lead to accumulation of the medicine. |
| Liver | Monitor | Chronic therapy can cause hepatotoxicity. |
| Lung | Urgent review | New cough/dyspnoea may indicate pneumonitis. |
| Driving | Caution | Other symptoms include fatigue and dizziness, which makes it dangerous to drive. |
Monitoring During Biotrexate 50mg/2ml Injection Treatment
- A complete blood count is done to measure red cells, white cells, and platelets, as methotrexate 50mg/2ml injection can affect your blood cell count.
- Creatinine and eGFR are measured to assess the ability of kidneys to clear the Biotrexate 50mg/2ml injection from the body.
- Blood tests for the liver are taken to identify any liver damage.
- In the case of high-dose methotrexate 50mg/2ml injection therapy, blood levels of the medicine are measured.
- Urinary pH is measured to assess the hydration status in order to help kidneys in clearing the medicine from the body.
- Any new cough or shortness of breath needs to be reported, as methotrexate 50mg/2ml injection may cause lung inflammation.
Biotrexate 50mg/2ml Injection Fact Box
| Parameter | Verified / publication wording |
|---|---|
| Brand | Biotrexate |
| Generic / Combination | Methotrexate |
| Strength | 50 mg/2 mL (25 mg/mL) |
| Form | Injection |
| Manufacturer / Marketer | Zydus |
| Pack | 1 vial |
| Storage | Below 30°C |
| Major safety theme | DOSING-ERROR WARNING |
| Prescription | Yes |
Biotrexate 50mg/2ml Injection Drug Interactions
| Drug / Class | Risk | What To Do |
|---|---|---|
| NSAIDs, PPIs and some antibiotics | Can delay methotrexate clearance, especially at high doses | The doctor may have to evaluate or discontinue them as per the prescribed course of treatment. |
| Trimethoprim/co-trimoxazole | Additive antifolate/myelosuppressive toxicity | Avoid unless specifically prescribed by the specialist. |
| Penicillins | May reduce renal clearance | Use only with medical advice and monitor closely. |
| Live vaccines | Infection risk during immunosuppression | Avoid unless the treating doctor advises otherwise. |
FAQs About Biotrexate 50mg/2ml Injection
Is the Biotrexate 50 mg dose always required?
No, 50 mg is the dosage of one vial only. The exact dosage depends on the condition and the treatment protocol that is applied.
Why is leucovorin needed when taking a high dose of methotrexate 50 mg/2 mL injection?
The administration of leucovorin protects healthy cells from being harmed by methotrexate injection. Its administration protocol depends on the level of methotrexate in blood.
Why is weekly administration crucial for arthritis?
Methotrexate 50 mg/2 mL Injection for arthritis is normally administered once per week. Administering it daily by mistake may lead to serious toxicity.
Is the Biotrexate injection to be administered directly to the spine?
It is only possible to administer a certain methotrexate 50 mg/2 mL injection, which should be free from preservatives.
Why is it important to have renal function tests while on methotrexate 50 mg/2 mL?
Methotrexate 50 mg/2 mL injection is mainly excreted via the kidneys. If the excretion rate is low, there may be excessive concentrations of the drug, leading to toxicity.
Are NSAIDs likely to interact with methotrexate injection?
There is a possibility of an interaction, especially at high dosages of Biotrexate 50 mg/2 mL injection. The physician will check for this possibility.
What symptoms require immediate action?
Fever, sore mouth, difficulty breathing, abnormal bleeding, or reduced urination compared to normal amounts.
References
- Current methotrexate injection prescribing information https://labeling.pfizer.com/ShowLabeling.aspx?id=5380
- Current NCCN/ALL/osteosarcoma protocols https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1418
- Current rheumatology guidelines for weekly methotrexate use https://pmc.ncbi.nlm.nih.gov/articles/PMC5386601/
Marketer Details
Zydus
Author Details
Written By:
Nonish Sharma
I am a medical content writer with a strong academic background in life sciences, holding an M.Sc. in Biotechnology... Read More
Reviewed By:
Vaibhav Shakya
Dr. Vaibhav Shakya, MD, is a Medical reviewer and medicine expert at Globans Pharma, with more than 9 years of experienc... Read More
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