ZUG, Switzerland, Dec. 18, 2015 /PRNewswire/ -- Turing Pharmaceuticals AG, a privately-held biopharmaceutical company focused on developing and commercializing innovative treatments for serious diseases and conditions, today emphasizes the continued availability of Daraprim and cautions healthcare providers of proposed alternatives to Daraprim.
In light of recent leadership changes at Turing Pharmaceuticals, there may be concerns regarding the continued availability of Daraprim. Turing assures healthcare providers and patients that Daraprim remains available and is unaffected by these events. Additionally, Turing has started to expand its distribution partnerships in the outpatient setting to ensure optimal patient access.
"Our priority continues to be supporting our healthcare providers and their patients to ensure that patients who need Daraprim have ready and affordable access to it," said Nancy Retzlaff, Turing's Chief Commercial Officer. "We pledge that no patient needing Daraprim will be denied access."
Despite Daraprim's availability, certain compounding pharmacies have announced that they have created unapproved fixed-dose combinations of pyrimethamine and leucovorin. These combinations are not approved by the U.S. Food and Drug Administration (FDA) for any use, nor have they been tested in accordance with FDA regulations to ensure safety to patients and equivalency to Daraprim. Daraprim is the only drug approved by the FDA in combination with a sulfonamide for the treatment of toxoplasmosis. Express Scripts and CVS Health Corp are offering these new products as valid alternatives to Daraprim. No data exists to demonstrate that these compounded products are acceptable alternatives to Daraprim.
The FDA ensures that products have demonstrated acceptable safety profiles and have well-defined efficacy based on clinical trials. The FDA also safeguards that manufacturing is performed under controlled processes that ensure the product is manufactured in a consistent manner. Compounded products are not subjected to these rigorous controls which may lead to suboptimal product that could impact patients' health. Since 2012, 90% of the 160 FDA inspections of compounding pharmacies identified "objectionable conditions."
Turing Pharmaceuticals is committed to ensuring patient access and affordability for Daraprim through the Daraprim Direct program. A copay mitigation program, patient assistance program for uninsured patients and donations to charitable organizations for Medicare Part D copay assistance help ensure Daraprim affordability for all patients. Turing is committed to the pledge that no patient needing Daraprim will be denied access.
Any patient or physician who needs access to Daraprim should go to www.daraprimdirect.com or contact our patient access hotline at 1-800-222-4991.
Daraprim is a prescription medication that contains pyrimethamine for the treatment of:
- Toxoplasmosis or acute malaria when used with a sulfonamide (e.g., sulfadoxine).
- Daraprim is not for use by itself to treat acute malaria and only for patients infected in areas where susceptible plasmodia (the parasite that causes malaria) exist. Other medicines such as chloroquine or quinine are preferred for the treatment of acute malaria.
- For prevention of malaria when the plasmodia is susceptible. It is not suitable as a prophylactic agent for travelers to most areas since resistance to pyrimethamine is prevalent worldwide.
IMPORTANT SAFETY INFORMATION
Do not use Daraprim if you:
- are allergic to pyrimethamine or any component of Daraprim
- have megaloblastic anemia due to folate deficiency
Taking Daraprim may result in allergic reactions that can be severe (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and anaphylaxis). Symptoms of an allergic reaction or the severe reactions may include: fever, body aches, facial or tongue swelling, skin pain, peeling of skin, blisters on your skin and mucous membranes, itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. At the first appearance of a skin rash or any of the above symptoms, stop the mediation and immediately seek medical attention. Other signs and symptoms of serious disorders may include sore throat, paleness, tongue changes, and purple skin color.
Make sure to tell your healthcare provider if you have any heart conditions, especially if you experience irregular heartbeat.
The most common side effects that may occur with Daraprim include allergic reactions (see above), blood disorders, tongue changes, blood in the urine, heart rhythm disorders, anorexia, and vomiting.
Tell your healthcare provider if you have any side effects while taking Daraprim.
Notify your healthcare provider if you become pregnant or intend to become pregnant during therapy or if you intend to breast-feed or are breast-feeding an infant.
Tell your healthcare provider if you have problems with your kidney or liver, decreased intestinal absorption problems, alcoholism, or any other medical conditions.
Make sure you tell your healthcare provider about all of the prescription and non-prescription medications you take, including supplements, and especially sulfonamides or trimethoprim-sulfamethoxazole combination, proguani (another antimalarial medicine), zidovudine (a medicine to treat Human Immunodeficiency Virus, HIV), or cytostatic agents (medicines that block cell division e.g., methotrexate, a medicine used for cancer or rheumatoid arthritis), phenytoin (a medicine to treat seizures), or lorazepam.
Be sure to take your medicine as instructed. Do not exceed the recommended dosage. You may take Daraprim with or without food. However, taking Daraprim with food may minimize associated anorexia and vomiting.
Keep out of the reach of infants and children: Deaths in pediatric patients have been reported after accidental ingestion.
Note: The above information for patients being treated with Daraprim is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects. Please read the Accompanying Full Prescribing Information and talk to your healthcare provider for more information concerning your treatment if you have questions, or go to turingpharma.com.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. To report SUSPECTED ADVERSE REACTIONS contact Turing Pharmaceuticals AG at 1-877-258-2033.
Turing Pharmaceuticals AG is a privately-held biopharmaceutical company with offices in Zug, Switzerland, and New York, New York. Turing focuses on developing and commercializing innovative treatments for serious diseases and conditions across a broad range of therapeutic areas, for which there are currently limited or no treatment options. Products being developed include intranasal ketamine for a variety of mood disorders and Syntocinon® (oxytocin nasal solution) for multiple indications. Daraprim (pyrimethamine) for the treatment of Toxoplasmosis in combination with sulfonamide and Vecamyl®(mecamylamine HCl tablets) for hypertension are Turing's first commercial products.
For more information, visit www.turingpharma.com.
In addition to historical facts or statements of current condition, this press release contains forward-looking statements within the meaning of "Safe Harbor" provisions of The Private Securities Litigation Reform Act of 1995, including statements regarding the initiation of product development activities, including but not necessarily limited to clinical trials. Forward-looking statements provide Turing Pharmaceuticals' current expectations and forecasts of future events. Turing Pharmaceuticals' performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Turing Pharmaceuticals undertakes no obligation to update publicly any forward-looking statements.
SOURCE Turing Pharmaceuticals AG