GNH USA

Europe — EMA

Levotonal

GNH USA supplies Levotonal (Calcium Levofolinate), a folate derivative for rescue therapy after high-dose methotrexate and folinic acid deficiency.

Calcium Levofolinate

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What is Calcium Levofolinate?

Calcium Levofolinate, the active ingredient in Levotonal, is a folate derivative presented as a sterile injectable solution for intramuscular and intravenous use. It provides a reduced form of folic acid that bypasses dihydrofolate reductase inhibition, helping to restore DNA synthesis and cell replication in patients receiving high‑dose methotrexate or with folinic acid deficiency.

GNH USA supplies Levotonal as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

What is Calcium Levofolinate used for?

Levotonal is employed in clinical situations where folate rescue or supplementation is required, particularly in oncology and chemotherapy protocols.

- Rescue therapy after high‑dose methotrexate: reduces toxicity and supports rapid cellular recovery. - Reduction of methotrexate toxicity: mitigates adverse effects in patients receiving methotrexate. - Folinic acid deficiency: restores folate‑dependent metabolic processes and normal cell division.

What are the side effects of Calcium Levofolinate?

Adverse reactions may occur with Levotonal administration.

Common Side Effects: - Nausea - Vomiting - Mild rash or erythema at injection site - Transient fever - Headache - Mild elevation of liver enzymes

Serious or Rare Side Effects: - Anaphylactic or severe allergic reactions - Acute hypotension - Acute renal failure - Severe hepatic dysfunction - Neutropenia - Thrombocytopenia

What precautions apply to Calcium Levofolinate?

Levotonal should be used with careful clinical monitoring.

- Assess renal function: adjust or monitor in patients with impaired renal clearance. - Monitor liver enzymes: watch for hepatic toxicity during therapy. - Check for hypersensitivity: discontinue if severe allergic reaction occurs. - Avoid concurrent high‑dose methotrexate without monitoring: coordinate dosing schedules. - Pregnancy considerations: use only if benefits outweigh potential risks. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

What does Calcium Levofolinate interact with?

Levotonal may interact with several agents used in oncology and supportive care.

Major Interactions (Avoid): - High‑dose methotrexate: concurrent use may increase folate rescue requirements. - Antifolates (e.g., pemetrexed): may reduce efficacy of calcium levofolinate. - Cytotoxic chemotherapy agents: may alter overall toxicity profile.

Moderate Interactions (Monitor Closely): - NSAIDs: may affect renal clearance of folate compounds. - Proton pump inhibitors: may influence absorption of oral folate derivatives. - Sulfonamides: possible additive bone‑marrow suppression when combined with folate antagonists.

Frequently asked questions

What is Levotonal used for?+
Levotonal is used as a folate rescue agent to reduce toxicity after high‑dose methotrexate therapy and to treat folinic acid deficiency. It helps restore normal DNA synthesis in rapidly dividing cells, supporting patients undergoing intensive chemotherapy or those with impaired folate metabolism.
How does Calcium Levofolinate work?+
Calcium Levofolinate provides a reduced form of folic acid that enters cells via the reduced folate carrier. It bypasses the dihydrofolate reductase block imposed by methotrexate, allowing conversion to tetrahydrofolate derivatives that supply one‑carbon units for thymidylate and purine synthesis, thereby restoring DNA replication.
What is the usual dose of Levotonal?+
The dose of Levotonal is individualized and determined by the prescribing clinician based on the specific indication, patient weight, renal function, and concurrent chemotherapy regimen. Healthcare professionals set the appropriate amount and schedule for each patient.
Is Levotonal safe in pregnancy or breastfeeding?+
The pregnancy safety category for Levotonal is not established. It should only be used during pregnancy or lactation when the potential benefits justify any possible risk to the fetus or infant, and after careful evaluation by the treating physician.
How do I order Levotonal from GNH USA?+
To order Levotonal, submit an enquiry on the product page at gnh-usa.com specifying the required quantity. GNH USA works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain handling if needed) and necessary import documentation.
How does Levotonal compare with the main alternative drug or class?+
The primary alternative to Levotonal is leucovorin (folinic acid). Both provide reduced folate to rescue cells from methotrexate toxicity, but calcium levofolinate is a calcium‑salt formulation that may offer improved stability for injectable use. Clinical choice depends on formulation preferences, dosing convenience and institutional protocols.
How should Levotonal be stored and handled?+
Levotonal must be stored refrigerated at 2‑8 °C. Keep the vials in their original packaging, protect them from light, and avoid freezing or shaking. If temperature excursions occur, discard the product according to local regulations.
How is Levotonal administered?+
Levotonal is supplied as a sterile solution for intramuscular or intravenous injection. Administration is performed by a qualified healthcare professional, typically shortly after high‑dose methotrexate infusion, following the dosing schedule prescribed by the treating physician.
What are the most serious risks to watch for?+
Serious adverse events include anaphylaxis, severe hypotension, acute renal failure, marked hepatic dysfunction, neutropenia and thrombocytopenia. Patients should be monitored closely for signs of allergic reaction, sudden drop in blood pressure, impaired kidney or liver function, and abnormal blood counts.
Who should not use Levotonal?+
Levotonal is contraindicated in patients with known hypersensitivity to calcium levofolinate or any component of the formulation. Caution is advised for individuals with severe renal or hepatic impairment, and it should be avoided in pregnant women unless the therapeutic benefit outweighs potential risks.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Calcium Levofolinate
Route
Intramuscular Use , Intravenous Use
Manufacturer
Pharmacare Srl
Origin
EU

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