About DESFERAL The need for iron chelation treatment Key Points About DESFERAL

Terms of Use

Your access to and use of this Site is subject to the following terms and conditions and all applicable laws. By accessing and browsing this Site, you accept, without limitation or qualification, these Terms and Conditions and acknowledge that any other agreements between you and Novartis Pharmaceuticals Corporation are superseded and of no force or effect.

  • You may download, display or print information from this Site (the "Information") solely for non-commercial personal use.
  • You must retain and reproduce each and every copyright notice or other proprietary rights notice contained in any Information you download. You may not, however, distribute, modify, transmit, reuse, repost, or use the content of the Site for public or commercial purposes, including the text, /images, audio, and video without written permission of Novartis Pharmaceuticals Corporation. You should assume that everything you see or read on this Site is copyrighted unless otherwise noted and may not be used except as provided in these Terms and Conditions or in the text on the Site without the written permission of Novartis Pharmaceuticals Corporation. Novartis Pharmaceuticals Corporation neither warrants nor represents that your use of materials displayed on the Site will not infringe rights of third parties not owned by or affiliated with Novartis Pharmaceuticals Corporation.
  • With the exception of the foregoing limited authorization, no license to or right in any copyright of Novartis Pharmaceuticals Corporation or of any other party is granted or conferred to you.

Back to Top

  • The Novartis Pharmaceuticals Corporation Internet sites may contain or reference trademarks, patents, proprietary information, technologies, products, processes or other proprietary rights of Novartis Pharmaceuticals Corporation and/or other parties. No license to or right in any such trademarks, patents, trade secrets, technologies, products, processes and other proprietary rights of Novartis Pharmaceuticals Corporation and/or other parties is granted to or conferred upon you.
  • While Novartis Pharmaceuticals Corporation uses reasonable efforts to include accurate and up-to-date information in the Site, Novartis Pharmaceuticals Corporation makes no warranties or representations with respect to the content of the Site, which is provided "as is." Novartis Pharmaceuticals Corporation accepts no responsibility or liability whatsoever arising from or in any way connected with the use of this Site or its content. In particular, Novartis Pharmaceuticals Corporation will not be liable for the accuracy, completeness, adequacy, timeliness, or comprehensiveness of the information contained on the Site. Some jurisdictions do not allow the exclusion of implied warranties, so the above exclusion may not apply to you. Novartis Pharmaceuticals Corporation also assumes no responsibility, and shall not be liable for any damages to, or viruses that may infect, your computer equipment or other property on account of your access to, use of, or browsing in the Site or your downloading of any materials, data, text, /images, video, or audio from the Site. Novartis Pharmaceuticals Corporation reserves the right to interrupt or discontinue any or all of the functionality of its Site. The Novartis Group entity controlling this Site accepts no responsibility or liability whatsoever for any interruption or discontinuance of any or all functionality of its Site, whether the result of actions or omissions of an entity of the Novartis Group or a third party.
  • Any communication or material you transmit to the Site by electronic mail or otherwise, including any data, questions, comments, suggestions or the like is, and will be treated as, non-confidential and non-proprietary. Anything you transmit or post becomes the property of Novartis Pharmaceuticals Corporation or its affiliates and may be used for any purpose, including, but not limited to, reproduction, disclosure, transmission, publication, broadcast and posting. Furthermore, Novartis Pharmaceuticals Corporation is free to use any ideas, concepts, know-how, or techniques contained in any communication you send to the Site for any purpose whatsoever including, but not limited to, developing, manufacturing and marketing products using such information.

Back to Top

  • The Information may contain technical inaccuracies or typographical errors. Novartis Pharmaceuticals Corporation reserves the right to make changes, corrections and/or improvements to the Information, and to the products and programs described in such information, at any time without notice.
  • Novartis Pharmaceuticals Corporation Internet sites contain information on its worldwide products and services, not all of which are available in every location. A reference to a Novartis Pharmaceuticals Corporation product or service on a Novartis Pharmaceuticals Corporation Internet site does not imply that such product or service is or will be available in your location.
  • Because Novartis Pharmaceuticals Corporation has no control over and does not endorse any of the sites to which the Site is linked and because Novartis Pharmaceuticals Corporation has not reviewed any or all of the sites to which the Site is linked, you acknowledge that Novartis Pharmaceuticals Corporation is not responsible for the content of any off-Site pages or any other sites linked to the Site. Your linking to the Site, off-Site pages or other sites is at your own risk and without the permission of Novartis Pharmaceuticals Corporation.
  • Although Novartis Pharmaceuticals Corporation may from time to time monitor or review discussions, chats, postings, transmissions, bulletin boards, and the like on the Site, Novartis Pharmaceuticals Corporation is under no obligation to do so and assumes no responsibility or liability arising from the content of any such locations nor for any error, defamation, libel, slander, omission, falsehood, obscenity, pornography, profanity, danger, or inaccuracy contained in any information within such locations on the Site. You are prohibited from posting or transmitting any unlawful, threatening, libelous, defamatory, obscene, scandalous, inflammatory, pornographic, or profane material or any material that could constitute or encourage conduct that would be considered a criminal offense, give rise to civil liability, or otherwise violate any law. Novartis Pharmaceuticals Corporation will fully cooperate with any law enforcement authorities or court order requesting or directing Novartis Pharmaceuticals Corporation to disclose the identity of anyone posting any such information or materials.

Back to Top

  • Novartis Pharmaceuticals Corporation may at any time revise these Terms and Conditions by updating this posting. You are bound by any such revisions and should therefore periodically visit this page to review the then current Terms and Conditions to which you are bound.
  • Links to this Site are permitted only to the home page. Deep linking is not permitted without the prior written consent of Novartis Pharmaceuticals Corporation.
  • Framing of this Site by sites or site elements of parties not part of the Novartis Group is not permitted. In-line linking or any other manner of incorporating parts of this Site in sites of parties not part of the Novartis group is equally prohibited.

Back to Top

DESFERAL is indicated for the treatment of acute iron intoxication and of chronic iron overload due to transfusion-dependent anemias.

DESFERAL is not indicated for the treatment of primary hemochromatosis, since phlebotomy is the method of choice for removing excess iron in this disorder.

 

 

Important Safety Information

DESFERAL is contraindicated in patients with severe renal disease or anuria, since the drug and the iron chelate are excreted primarily by the kidney.

Ocular and auditory disturbances have been reported when DESFERAL was administered over prolonged periods of time, at high doses, or in patients with low ferritin levels. The ocular disturbances observed have been blurring of vision; cataracts after prolonged administration in chronic iron overload; decreased visual acuity including visual loss, visual defects, scotoma; impaired peripheral, color, and night vision; optic neuritis, cataracts, corneal opacities, and retinal pigmentary abnormalities. The auditory abnormalities reported have been tinnitus and hearing loss, including high frequency sensorineural hearing loss. In most cases, both ocular and auditory disturbances were reversible upon immediate cessation of treatment. In the geriatric population, postmarketing reports suggest a possible trend for an increased risk of eye disorders (specifically the occurrence of blindness, maculopathy, and scotoma), deafness and hearing loss.

Visual acuity tests, slit-lamp examinations, funduscopy and audiometry are recommended periodically in patients treated for prolonged periods of time. Toxicity is more likely to be reversed if symptoms or test abnormalities are detected early.

High doses of DESFERAL and concomitant low ferritin levels have also been associated with growth retardation. After reduction of DESFERAL dose, growth velocity may partially resume to pretreatment rates. Pediatric patients receiving DESFERAL should be monitored for body weight and growth every 3 months.

Adult respiratory distress syndrome, also reported in children, has been described following treatment with excessively high intravenous doses of DESFERAL in patients with acute iron intoxication or thalassemia.

Flushing of the skin, urticaria, hypotension, and shock have occurred in a few patients when DESFERAL was administered by rapid intravenous injection. THEREFORE, DESFERAL SHOULD BE GIVEN INTRAMUSCULARLY OR BY SLOW SUBCUTANEOUS OR INTRAVENOUS INFUSION.

Iron overload increases susceptibility of patients to Yersinia enterocolitica and Yersinia pseudotuberculosis infections. In some rare cases, treatment with DESFERAL has enhanced this susceptibility, resulting in generalized infections by providing this bacteria with a siderophore otherwise missing. In such cases, DESFERAL treatment should be discontinued until the infection is resolved.

In patients receiving DESFERAL, rare cases of mucormycosis, some with a fatal outcomes, have been reported. If any of the suspected signs or symptoms occur, DESFERAL should be discontinued, mycological tests carried out and appropriate treatment instituted immediately.

In patients with severe chronic iron overload, impairment of cardiac function has been reported following concomitant treatment with DESFERAL and high doses of vitamin C (more than 500 mg daily in adults). The cardiac dysfunction was reversible when vitamin C was discontinued. Precautions should be taken when vitamin C and DESFERAL are used concomitantly.

In patients with aluminum-related encephalopathy, high doses of DESFERAL may exacerbate neurological dysfunction (seizures), probably owing to an acute increase in circulating aluminum. DESFERAL may precipitate the onset of dialysis dementia. Treatment with DESFERAL in the presence of aluminum overload may result in decreased serum calcium and aggravation of hyperparathyroidism.

The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency.

At the Injection Site: Localized irritation, pain, burning, swelling, induration, infiltration, pruritus, erythema, wheal formation, eschar, crust, vesicles, local edema. Injection site reactions may be associated with systemic allergic reactions including arthralgia, fever, headache, myalgia, nausea, vomiting, abdominal pain, or asthma.

Hypersensitivity Reactions and Systemic Allergic Reactions: Generalized rash, urticaria, anaphylactic reaction with or without shock, angioedema.

Cardiovascular: Tachycardia, hypotension, shock.

Digestive: Abdominal discomfort, diarrhea, nausea, vomiting.

Hematologic: Blood dyscrasia (e.g., thrombocytopenia, leukopenia).

Musculoskeletal: Leg cramps. Growth retardation and bone changes (e.g., metaphyseal dysplasia) are common in chelated patients given doses above 60 mg/kg, especially those who begin iron chelation in the first three years of life. If doses are kept to 40 mg/kg or below, the risk may be reduced.

Nervous System: Neurological disturbances including dizziness, peripheral sensory, motor, or mixed neuropathy, paresthesias; exacerbation or precipitation of aluminum-related dialysis encephalopathy.

Special Senses: High-frequency sensorineural hearing loss and/or tinnitus are uncommon if dosage guidelines are not exceeded and if dose is reduced when ferritin levels decline. Visual disturbances are rare if dosage guidelines are not exceeded. These may include decreased acuity, blurred vision, loss of vision, dyschromatopsia, night blindness, visual field defects, scotoma, retinopathy (pigmentary degeneration), optic neuritis, and cataracts.

Respiratory: Acute respiratory distress syndrome (with dyspnea, cyanosis, and/or interstitial infiltrates).

Skin: Very rare generalized rash.

Urogenital: Dysuria, impaired renal function.