Leucovorin Calcium Injection USP (Calcium Folinate equivalent to Folinic Acid) 10mg/ml (50mg/5ml) Technical Specification: 

Product Name:Leucovorin Calcium Injection USP (Calcium Folinate equivalent to Folinic Acid) 10mg/ml (50mg/5ml)
Brand Name:Leucovorin
Strength:10mg/ml (50mg/5ml, 100mg/10ml, 175mg/17.5ml, 250mg/25ml, 300mg/30ml, 500mg/50ml – VIAL)
15mg/ 2ml – Ampoule
Dosage Form:Liquid Injection
Packing:SINGLE USE VIAL
Route of Administration:For I.M. and I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-Cancer
Indication: Folinic acid, also known as leucovorin, is a medication used alone or with other drugs to treat certain types of colorectal cancer and anemia and to lessen the toxic effects of the anticancer drug methotrexate or other substances that block the action of folic acid.
Storage:Store between 2°-8° C (36°-46°F). Do not freeze. Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Leucovorin Calcium Injection USP (Calcium Folinate equivalent to Folinic Acid) 10mg/ml (50mg/5ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Leucovorin Calcium Injection USP (Calcium Folinate equivalent to Folinic Acid) 10mg/ml (50mg/5ml)
    Each ml contains
    Calcium Folinate USP
    Equivalent to
    Folinic Acid……………….…….10mg
    Methyl paraben B.P………..0.08% w/v
    Propyl paraben B.P…………0.02% w/v
    Water for Injection B.P……q.s.

THERAPEUTIC INDICATION:

Folinic acid, also known as leucovorin, is a medication used alone or with other drugs to treat certain types of colorectal cancer and anemia and to lessen the toxic effects of the anticancer drug methotrexate or other substances that block the action of folic acid.

PACKING:

10mg/ml – VIAL

  • 50mg/5ml
  • 100mg/10ml
  • 175mg/17.5ml
  • 250mg/25ml
  • 300mg/30ml
  • 500mg/50ml

15mg/ 2ml – Ampoule

DIRECTION OF USE:

For I.M. and I.V. use only

See package insert for complete prescribing information.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after dilution.
CAUTION: Cytotoxic agent – Special Handling.
WARNING: Cytotoxic Agent – To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
WARNINGS: IN THE TREATMENT OF ACCIDENTAL OVERDOSAGES OF FOLIC ACID ANTAGONISTS, INTRAVENOUS LEUCOVORIN SHOULD BE ADMINISTERED AS PROMPTLY AS POSSIBLE. AS THE TIME INTERVAL BETWEEN ANTIFOLATE ADMINISTRATION (E.G. METHOTREXATE) AND LEUCOVORIN RESCUE INCREASES, LEUCOVORIN’S EFFECTIVENESS IN COUNTERACTING TOXICITY DECREASES. IN THE TREATMENT OF ACCIDENTAL OVERDOSAGES OF INTRATHECALLY ADMINISTER LEUCOVORIN INTRATHECALLY, LEUCOVORIN MAY BE HARMFUL OR FATAL IF GIVEN INTRATHECALLY.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of reach of children.

STORAGE & DOSAGE:

Storage: Store between 2°-8° C (36°-46°F). Do not freeze. Protect from light.
Dosage: As directed by the Oncologist.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is a pharmaceutical company that stands out as a trusted provider of Leucovorin Calcium Injection USP for several compelling reasons. With a rich legacy in the pharmaceutical industry, Taj Pharmaceuticals brings decades of experience and deep expertise to the forefront. This extensive knowledge ensures the consistent quality and effectiveness of medications like Leucovorin Calcium Injection, instilling confidence in both healthcare providers and patients. One of the hallmarks of Taj Pharmaceuticals is its unwavering commitment to maintaining the highest standards of quality and safety in pharmaceutical products. Their manufacturing processes are marked by precision and rigorously enforced quality control measures. This commitment underscores their reputation as a pharmaceutical provider of choice.

Taj Pharmaceuticals operates as an exporter from India, playing a crucial role in making essential medications, including Leucovorin Calcium Injection, accessible to healthcare providers and patients across the globe. Their extensive global distribution network ensures the availability of vital medications in various regions, contributing to improved healthcare on an international scale. Within its state-of-the-art pharmaceutical manufacturing facilities, Taj Pharmaceuticals leverages cutting-edge technology to produce accurate and consistent medications. These facilities serve as the backbone of their commitment to quality, as they strive to provide pharmaceutical products that meet the highest standards of reliability and safety.

Taj Pharmaceuticals is driven by a patient-centric approach, placing the well-being of individuals at the forefront of its mission. By consistently delivering dependable medications like Leucovorin Calcium Injection, they demonstrate a genuine dedication to improving patient health and enhancing overall quality of life. The company’s proven track record within the healthcare community underscores its commitment to quality and safety. This record has earned the trust of healthcare professionals and institutions, solidifying Taj Pharmaceuticals’ position as a reliable pharmaceutical partner. In addition to their commitment to excellence, Taj Pharmaceuticals often offers a variety of formulations for medications, catering to different patient needs and preferences. This flexibility further enhances their reputation as a trusted pharmaceutical provider, making them a valuable resource in the field of healthcare.

What is Leucovorin Calcium Injection USP and its uses?

Leucovorin Calcium Injection USP is a medication that contains leucovorin calcium as its active ingredient. It is used for various medical purposes, primarily in the field of oncology and certain other medical conditions. Here’s an overview of Leucovorin Calcium Injection and its common uses:

  • Medication Type: Leucovorin Calcium is a derivative of folic acid (vitamin B9). It is a coenzyme that plays a crucial role in several metabolic pathways in the body.
  • Mechanism of Action:
    Leucovorin Calcium is often used as a “rescue” medication in cancer treatment. It works by providing an exogenous (external) source of active folate, which is essential for DNA synthesis and repair.
    In cancer treatment, certain chemotherapy drugs, like methotrexate, can interfere with folate metabolism, affecting both cancer cells and healthy cells. Leucovorin Calcium helps protect healthy cells by “rescuing” them from the toxic effects of methotrexate.

Common Uses of Leucovorin Calcium Injection USP:

  • Cancer Treatment: Leucovorin Calcium is frequently used in cancer therapy, particularly in combination with methotrexate. It helps reduce the toxic effects of methotrexate on healthy cells while allowing the chemotherapy drug to target cancer cells effectively. This is known as “leucovorin rescue.”
  • Folate Deficiency: In some cases of folate deficiency, either due to inadequate dietary intake or certain medical conditions, Leucovorin Calcium may be administered to supplement folate levels in the body.
  • Antidote for Overdose: Leucovorin Calcium can serve as an antidote for overdoses of certain medications, including methotrexate. It helps counteract the toxic effects of these drugs.
  • Radiation Therapy: It may be used in combination with radiation therapy in the treatment of certain types of cancer.
  • Psoriasis: In some cases of severe psoriasis that does not respond to other treatments, Leucovorin Calcium may be considered as a treatment option.

It’s important to note that the use of Leucovorin Calcium Injection is determined by a healthcare provider based on the specific medical condition, the type of cancer, and the individual patient’s needs. Patients should follow their healthcare provider’s instructions regarding the dosage and duration of treatment with this medication to ensure its effectiveness and safety. Additionally, individuals should inform their healthcare provider of any allergies or other medications they are taking to avoid potential interactions or adverse reactions.

How Does Leucovorin Calcium Injection USP Work?

Leucovorin Calcium Injection USP works by providing a crucial substance called leucovorin (also known as folinic acid) to the body. Leucovorin is a form of folate, which is a B vitamin essential for various metabolic processes, particularly DNA synthesis and repair. Here’s how Leucovorin Calcium Injection works:

  • Folate Metabolism: Folate, or vitamin B9, plays a vital role in the synthesis of DNA, RNA, and proteins. It’s especially important during cell division, as it helps create the building blocks necessary for replicating genetic material and producing new cells.
  • Chemotherapy and Methotrexate: In cancer treatment, certain chemotherapy drugs, such as methotrexate, are used to target rapidly dividing cells, including cancer cells. However, methotrexate also affects healthy cells that need folate for their own growth and division.
  • Methotrexate Inhibition: Methotrexate inhibits an enzyme called dihydrofolate reductase (DHFR), which is involved in folate metabolism. By inhibiting DHFR, methotrexate interferes with the synthesis of DNA and RNA in both cancer cells and normal, healthy cells.
  • Leucovorin Rescue: Leucovorin Calcium Injection is used as a rescue or “folinic acid rescue” therapy in cancer treatment. It contains leucovorin, which is essentially a form of folate that bypasses the need for DHFR. When administered, leucovorin can provide a source of active folate directly to cells, including healthy cells that are affected by methotrexate.
  • Protecting Healthy Cells: Leucovorin effectively “rescues” healthy cells from the toxic effects of methotrexate. By providing an alternative source of folate that bypasses the blocked DHFR enzyme, leucovorin ensures that normal cells can continue their essential metabolic processes and avoid the damage caused by methotrexate.
  • Selective Effect on Cancer Cells: Importantly, while leucovorin protects healthy cells, it doesn’t significantly interfere with the action of methotrexate on cancer cells. Cancer cells, often characterized by rapid division and higher demand for folate, continue to be affected by methotrexate even in the presence of leucovorin.

Benefits of Leucovorin Calcium Injection USP:

  • Effective “Rescue” in Cancer Treatment: The primary benefit of Leucovorin Calcium Injection is its role as a rescue medication during cancer treatment. It protects healthy cells from the toxic effects of certain chemotherapy drugs, such as methotrexate, allowing those cells to continue functioning normally. This is particularly important in reducing side effects in cancer patients.
  • Minimizing Chemotherapy Side Effects: By providing an alternative source of folate that bypasses the blocked enzyme targeted by methotrexate, Leucovorin Calcium helps minimize side effects such as mucositis (inflammation of the mucous membranes), bone marrow suppression, and gastrointestinal discomfort that can result from chemotherapy.
  • Enhancing Chemotherapy Effectiveness: While protecting healthy cells, Leucovorin Calcium does not significantly interfere with the action of chemotherapy drugs on cancer cells. This allows chemotherapy to remain effective in targeting and inhibiting the growth of cancerous tissues.

Common Side Effects of Leucovorin Calcium Injection USP:

  • Allergic Reactions: Although rare, some individuals may experience allergic reactions to Leucovorin Calcium Injection. Signs of an allergic reaction may include skin rash, itching, swelling, dizziness, or difficulty breathing. Seek immediate medical attention if any of these symptoms occur.
  • Gastrointestinal Disturbances: Some patients may experience gastrointestinal side effects, including nausea, vomiting, diarrhea, or abdominal pain. These side effects are generally mild and can often be managed with proper medication and adjustments to treatment.
  • Local Injection Site Reactions: Pain, redness, or irritation at the site of injection can occur but are usually temporary and resolve on their own.

It’s important to remember that the benefits of Leucovorin Calcium Injection in cancer treatment far outweigh the potential side effects. The medication’s ability to protect healthy cells while enhancing the effectiveness of chemotherapy is crucial in improving the overall quality of life for cancer patients. Patients should follow their healthcare provider’s instructions regarding the dosage and administration of Leucovorin Calcium Injection. They should also promptly report any severe or unusual side effects to their healthcare provider. Additionally, informing the healthcare provider of any allergies or other medications being taken is important to avoid potential interactions or adverse reactions.

Frequently Asked Questions About Leucovorin Calcium Injection:

Certainly, here are some frequently asked questions (FAQs) about Leucovorin Calcium Injection USP:

  • What is Leucovorin Calcium Injection used for?

Leucovorin Calcium Injection is primarily used as a “rescue” medication in cancer treatment to protect healthy cells from the toxic effects of certain chemotherapy drugs, such as methotrexate. It is also used in cases of folate deficiency and as an antidote for overdoses of specific medications.

  • How does Leucovorin Calcium Injection work in cancer treatment?

Leucovorin Calcium provides an external source of active folate, which is essential for DNA synthesis and repair. By bypassing the blocked enzyme targeted by chemotherapy drugs like methotrexate, Leucovorin Calcium protects healthy cells while allowing the chemotherapy drug to effectively target cancer cells.

  • Is Leucovorin Calcium Injection safe for all cancer patients?

Leucovorin Calcium Injection is generally considered safe and effective when prescribed by a healthcare provider. However, its use may vary based on the specific chemotherapy regimen, the type and stage of cancer, and individual patient factors. Consult with a healthcare provider for personalized treatment recommendations.

  • Are there any potential allergic reactions to this injection?

While allergic reactions to Leucovorin Calcium Injection are rare, they can occur. Allergic symptoms may include skin rash, itching, swelling, dizziness, or difficulty breathing. Seek immediate medical attention if any signs of an allergic reaction are experienced.

  • Can Leucovorin Calcium Injection be administered at home?

In most cases, Leucovorin Calcium Injection is administered in a clinical setting by healthcare professionals. Home administration may be considered in specific situations, but it should be guided and supervised by a healthcare provider.

  • Are there any dietary restrictions while receiving Leucovorin Calcium Injection?

There are typically no specific dietary restrictions associated with Leucovorin Calcium Injection. However, patients should follow their healthcare provider’s dietary recommendations, especially if they have specific dietary concerns or restrictions.

  • What should I do if I miss a dose of Leucovorin Calcium Injection?

It’s crucial to adhere to the prescribed treatment schedule. If a dose is missed or if you have any concerns about missed doses, contact your healthcare provider for guidance.

  • Can Leucovorin Calcium Injection interact with other medications?

Leucovorin Calcium may interact with certain medications, so it’s essential to inform your healthcare provider of all medications, supplements, or herbal products you are taking. They can assess potential interactions and adjust your treatment plan accordingly. Patients should consult their healthcare provider for personalized information and guidance regarding the use of Leucovorin Calcium Injection. Treatment decisions should be based on individual circumstances and medical guidelines.

As Leucovorin Calcium Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Leucovorin Calcium Injection product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Leucovorin Calcium Injection Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Leucovorin Calcium Injection, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Leucovorin Calcium Injection USP (Calcium Folinate equivalent to Folinic Acid) 10mg/ml (50mg/5ml, 100mg/10ml, 175mg/17.5ml, 250mg/25ml, 300mg/30ml, 500mg/50ml - VIAL)
b) Leucovorin Calcium Injection USP (Calcium Folinate equivalent to Folinic Acid) 15mg/ 2ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Leucovorin Calcium Injection USP (Calcium Folinate equivalent to Folinic Acid) 10mg/ml (50mg/5ml, 100mg/10ml, 175mg/17.5ml, 250mg/25ml, 300mg/30ml, 500mg/50ml - VIAL)
Each ml contains
Calcium Folinate USP
Equivalent to
Folinic Acid……………….…....10mg
Methyl paraben B.P………..0.08% w/v
Propyl paraben B.P………...0.02% w/v
Water for Injection B.P…...q.s.


b) Leucovorin Calcium Injection USP (Calcium Folinate equivalent to Folinic Acid) 15mg/ 2ml
Each ml of 15 mg contains
Leucovorin Calcium USP
equivalent to Leucovorin………………..7.5 mg
Water for Injection …………………………q.s
The solution contains no preservatives

THERAPEUTIC INDICATION:

Folinic acid, also known as leucovorin, is a medication used alone or with other drugs to treat certain types of colorectal cancer and anemia and to lessen the toxic effects of the anticancer drug methotrexate or other substances that block the action of folic acid.

PACKING:

10mg/ml - VIAL
1) 50mg/5ml
2) 100mg/10ml
3) 175mg/17.5ml
4) 250mg/25ml
5) 300mg/30ml
6) 500mg/50ml

15mg/ 2ml – Ampoule

DIRECTION OF USE:

For I.M. and I.V. use only
See package insert for complete prescribing information.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after dilution.
CAUTION: Cytotoxic agent – Special Handling.
WARNING: Cytotoxic Agent - To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
WARNINGS: IN THE TREATMENT OF ACCIDENTAL OVERDOSAGES OF FOLIC ACID ANTAGONISTS, INTRAVENOUS LEUCOVORIN SHOULD BE ADMINISTERED AS PROMPTLY AS POSSIBLE. AS THE TIME INTERVAL BETWEEN ANTIFOLATE ADMINISTRATION (E.G. METHOTREXATE) AND LEUCOVORIN RESCUE INCREASES, LEUCOVORIN’S EFFECTIVENESS IN COUNTERACTING TOXICITY DECREASES. IN THE TREATMENT OF ACCIDENTAL OVERDOSAGES OF INTRATHECALLY ADMINISTER LEUCOVORIN INTRATHECALLY, LEUCOVORIN MAY BE HARMFUL OR FATAL IF GIVEN INTRATHECALLY.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of reach of children.

STORAGE & DOSAGE:

Storage: Store between 2°-8° C (36°-46°F). Do not freeze. Protect from light.
Dosage: As directed by the Oncologist.