Product image of Normosang (Human Hemin) supplied by GNH India

Normosang

Active Ingredient:
Human Hemin
Origin:
EU

Normosang (Human Hemin)

Human Hemin, the active ingredient in Normosang, is a heme (heme analog) presented as an injectable solution for intravenous use. It is employed to treat acute intermittent porphyria and other acute hepatic porphyrias by supplying exogenous heme during attacks, helping to normalize heme‑dependent enzymatic pathways.

GNH India supplies Normosang as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres and specialty clinics worldwide, ensuring quality‑controlled delivery, regulatory compliance, and reliable cold‑chain logistics across global markets for acute care and research purposes.

Manufacturer / TM Owner

Recordati Rare Diseases

1
Pack/s
This product is added to your enquiry list

Request a Quote

Please fill out the form below and our team will get back to you shortly with pricing and further information.

A minimum order value applies. Our team will confirm the exact amount or quantity after reviewing your requirements.

Indications & Clinical Uses

  • Normosang acts on the heme biosynthesis pathway to manage acute porphyria attacks.
  • Acute intermittent porphyria: reduces the severity and duration of acute attacks by restoring heme feedback inhibition.
  • Acute hepatic porphyria (non‑AIP): alleviates symptoms such as abdominal pain and neuro‑visceral manifestations during crises.
  • Porphyria‑induced neurotoxicity: helps prevent progression of neurological complications by decreasing toxic porphyrin precursors.

How It Works

  • Human Hemin provides exogenous heme that re‑establishes negative feedback on aminolevulinic acid synthase (ALAS1), the rate‑limiting enzyme of the hepatic heme synthesis pathway. By suppressing ALAS1 activity, accumulation of aminolevulinic acid and porphobilinogen is reduced, thereby limiting the toxic precursors that trigger acute porphyria attacks. The restored heme pool also supports cytochrome P450 enzymes and improves cellular metabolic stability during the crisis.

Side Effects

Human Hemin may be associated with a range of adverse reactions, varying from mild infusion‑related events to rare serious complications.

Common Side Effects

  • Infusion site pain: discomfort or burning at the injection site.
  • Fever or chills: transient temperature elevation during or after infusion.
  • Nausea or vomiting: gastrointestinal upset following administration.
  • Headache or hypertension: mild increase in blood pressure or head pain.

Serious or Rare Side Effects

  • Anaphylactic reaction: severe allergic response requiring immediate medical intervention.
  • Hemolysis in G6PD‑deficient patients: rapid destruction of red blood cells.
  • Acute renal failure: sudden loss of kidney function, especially with high‑dose or prolonged therapy.

Precautions & Warnings

  • When using Normosang, several precautions should be observed to ensure patient safety.
  • Assess G6PD deficiency: avoid use in patients with known deficiency due to hemolysis risk.
  • Monitor liver function: hemin may affect hepatic enzymes, requiring periodic testing.
  • Check renal function: patients with pre‑existing kidney disease need close observation.
  • Avoid rapid infusion: administer over recommended period to reduce cardiovascular stress.
  • Pregnancy and lactation: safety not established; use only if benefit outweighs risk.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Human Hemin can interact with other medicines, necessitating careful review of a patient's medication list.

Major Interactions (Avoid)

  • Porphyrinogenic drugs (e.g., barbiturates, sulfonamides, antiepileptics): can precipitate attacks despite hemin therapy.
  • Concurrent heme preparations: may cause excess iron load and toxicity.
  • Vitamin K antagonists (warfarin): hemin may potentiate anticoagulant effect, increasing bleeding risk.

Moderate Interactions (Monitor Closely)

  • CYP450 inducers (e.g., rifampicin, carbamazepine): may reduce hemin efficacy.
  • Iron supplements: can increase iron burden, monitor ferritin levels.
  • Antihypertensive agents: hemin‑induced hypertension may require dose adjustment.

Frequently Asked Questions

Normosang is a prescription injectable that contains human hemin. It is indicated for the treatment of acute attacks of acute intermittent porphyria and other acute hepatic porphyrias, helping to reduce the buildup of toxic porphyrin precursors and alleviate severe symptoms such as abdominal pain, nausea, and neuro‑visceral disturbances.

Human Hemin supplies exogenous heme, which restores the normal negative feedback on the enzyme aminolevulinic acid synthase (ALAS1) in the liver. This feedback suppresses the over‑production of aminolevulinic acid and porphobilinogen, the toxic intermediates that trigger acute porphyria attacks, thereby stabilizing the heme biosynthetic pathway.

The dose of Normosang is determined by the prescribing clinician based on the severity of the porphyria attack, the patient’s weight, renal and hepatic function, and response to prior therapy. Dosing regimens are individualized and should follow the specific recommendations provided in the product’s prescribing information.

Safety data for Normosang in pregnancy and lactation are limited. The product should only be used when the potential benefit to the mother outweighs any possible risk to the fetus or infant. Clinicians should discuss the uncertainties with the patient and consider alternative therapies when appropriate.

To order Normosang, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain where required) and necessary import documentation.

The primary alternative to hemin therapy is high‑dose glucose infusion, which can suppress ALAS1 indirectly. Hemin provides a more direct and rapid replenishment of heme, often resulting in faster symptom control. However, glucose therapy may be used when hemin is unavailable or contraindicated, though it generally requires higher doses and longer administration periods.

Normosang should be stored at 2‑8 °C in a refrigerator. Keep the vial in its original packaging, protect it from light, and avoid freezing or shaking the solution. Once removed from refrigeration, use the product within the time frame specified in the label and discard any unused portion.

Normosang is given as an intravenous infusion. The recommended infusion rate and duration are outlined in the prescribing information and should be followed to minimize infusion‑related reactions. Administration is typically performed by a qualified healthcare professional in a setting equipped to manage potential adverse events.

The most serious risks include anaphylactic or severe allergic reactions, hemolysis in patients with glucose‑6‑phosphate dehydrogenase (G6PD) deficiency, and acute renal failure, especially with high‑dose or prolonged treatment. Early recognition and prompt medical intervention are essential to mitigate these potentially life‑threatening complications.

Normosang is contraindicated in patients with known hypersensitivity to human hemin or any excipients in the formulation. It should also be avoided in individuals with confirmed G6PD deficiency due to the risk of hemolysis, and in patients where the risk of severe infusion reactions outweighs the expected therapeutic benefit.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

Disclaimer

At GNH India, we aim to provide information that is expert-reviewed, accurate, and reliable. However, all content on this platform is intended for general informational purposes only and does not constitute professional medical advice, diagnosis, or treatment. While efforts are made to maintain accuracy and currency, the information may contain errors, omissions, or may not reflect the latest developments. Always consult a qualified healthcare professional regarding any medical concerns.

All product names, brand names, trademarks and registered trademarks displayed on this website are the property of their respective owners. This website and its operator are not affiliated with, endorsed by, or authorized by any such trade mark owners unless expressly stated. Any reference to product names or trademarks is made solely for descriptive and informational purposes. No commercial relationship, sponsorship, approval, or association with any trademark owner should be inferred. Information provided herein does not constitute promotion, advertising, or an offer for sale of any medicinal product and is intended solely for general informational purposes.

All trademarks and brand names displayed on this website are used strictly in accordance with the provisions of the Trade Marks Act, 1999, specifically Sections 30 and 30(1) governing fair use. Trademark ownership has been accurately attributed under the "Manufacturer/ TM Owner" section in compliance with statutory requirements.

Ordering Process

Simple, Secure, and Seamless

Learn how our streamlined ordering process guarantees fast, compliant, and reliable access to essential medicines worldwide.

Quote request form

01

Submit Quote Request Form

Tell us what medications you need by filling out our simple form and uploading a valid document.

Price estimate review

02

We Review & Send Estimate

Our licensed pharmacists will verify your details and provide you with a detailed cost estimate.

Secure payment

03

Confirm & Make Payment

Discuss any queries, approve the estimate, and complete your payment.

Worldwide delivery

04

Get Delivered

Your medicines, safely packed and delivered to your door or nearest airport — hassle-free.

Quality You Can Trust

Our internationally recognized certifications underscore our commitment to safety, quality, and excellence.