Oakrum Pharma Announces the Launch of Toxo Total Care Patient Services Program to Support Pyrimethamine 25mg Tablets

SAINT LOUIS, Mo., April 15, 2020 (GLOBE NEWSWIRE) -- Oakrum Pharma, LLC (“Oakrum”) announced today the launch of Toxo Total Care patient services program.

The Toxo Total Care program was created by Oakrum to provide patients with toxoplasmosis and their healthcare providers the quality and service of a branded specialty drug for its authorized generic pyrimethamine 25 mg tablets. Some of the anticipated benefits of the Toxo Total Care program include:

• Assisting with benefits investigation and insurance processing support;
  
• Dispensing and delivering to the patient’s home or a physician’s office;
  
• Informing and educating patients regarding assistance programs, including a copay card for commercially-insured patients; and
  
• Providing ongoing therapy management support.

The Toxo Total Care program is offered by Oakrum through Optime Care Inc., a St. Louis-based, nationally licensed, specialty pharmacy and wholesale distributor. Oakrum selected Optime Care to administer the Toxo Total Care program because of Optime Care’s commitment to support patients and their caregivers with dedicated programs and services aimed at helping patients to access important medicines and therapies.

For more information about the Toxo Total Care program, please call

1-833-TOXOMED (1-833-869-6633).

Oakrum AG Pyrimethamine Important Safety Information (ISI) Indications

Pyrimethamine is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide.

IMPORTANT SAFETY INFORMATION

• Pyrimethamine is contraindicated in patients with known hypersensitivity to pyrimethamine or to any component of the formulation and in patients with documented megaloblastic anemia due to folate deficiency.
  
• Potential for folate deficiency: Dosage required for toxoplasmosis treatment approaches the toxic level. If signs of folate deficiency develop, reduce the dosage or discontinue the drug according to patient response. Administer folinic acid (leucovorin) at 5-15 mg per day until normal hematopoiesis is restored.
  
• Carcinogenic potential: Data indicates that pyrimethamine may be carcinogenic.
  
• Adverse reactions:
  
  • Hypersensitivity reactions, occasionally severe (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and anaphylaxis), and hyperphenylalaninemia, can occur particularly when pyrimethamine is administered concomitantly with a sulfonamide. Consult the full prescribing information for relevant sulfonamide-associated adverse events.
    
  • Megaloblastic anemia, leukopenia, thrombocytopenia, pancytopenia, neutropenia, atrophic glossitis, hematuria, cardiac rhythm disorders, anorexia and vomiting may occur with doses used for toxoplasmosis treatment. Hematologic effects may also occur at low doses in certain individuals.
    
  • Pulmonary eosinophilia has been reported rarely.
    
• Pregnancy Category C:
  
  • There are no adequate and well-controlled studies in pregnant women. Pyrimethamine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Women of childbearing potential should be warned against becoming pregnant during treatment with pyrimethamine.
    
• Pyrimethamine is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from pyrimethamine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
  
• Keep out of the reach of infants and children: Deaths in pediatric patients have been reported after accidental ingestion.
  
• Drug Interactions:
  
  • The concomitant use of pyrimethamine with other antifolic drugs or agents associated with myelosuppression including sulfonamides or trimethoprim-sulfamethoxazole combination, proguanil, zidovudine, or cytostatic agents (e.g., methotrexate), may increase the risk of bone marrow suppression. If signs of folate deficiency develop, pyrimethamine should be discontinued and folinic acid should be given until hematopoiesis is restored (see above).
    
  • Use pyrimethamine with caution in patients receiving therapy, such as phenytoin, that affect folate levels.
    
  • Mild hepatotoxicity can occur when lorazepam and pyrimethamine are administered concomitantly.
    
• Dosing Information:
  
  • For specific dosing instructions see the Full Prescribing Information.
    
  • Do not exceed the recommended dosage.
    
  • Start with a small dose for toxoplasmosis in patients with convulsive disorders to avoid the potential nervous system toxicity of pyrimethamine (see Overdosage).
    
  • Use with caution in patients with impaired renal or hepatic function; in patients with possible folate deficiency such as individuals with malabsorption syndrome, alcoholism, or who are pregnant; and in the elderly due to the potential for decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy in this population.
    
  • Concurrent administration of folinic acid is strongly recommended when used for the treatment of toxoplasmosis in ALL patients.
    
  • In patients receiving a high dosage, semiweekly blood counts, including platelet counts should be performed.
    
  • Taking pyrimethamine with meals may minimize associated anorexia and vomiting.
    
• Overdosage:
  
  • Following the ingestion of 300 mg or more of pyrimethamine, gastrointestinal and/or central nervous system signs may be present, including convulsions and death.
    
  • There is no specific antidote to acute pyrimethamine poisoning. Symptomatic and supportive measures should be employed. Gastric lavage is recommended and is effective if carried out very soon after drug ingestion. Parenteral diazepam may be used to control convulsions. Folinic acid should be administered within 2 hours of drug ingestion to be most effective in counteracting the effects on the hematopoietic system. Daily monitoring of peripheral blood counts is recommended for up to several weeks until normal hematologic values are restored.

Please See Full Prescribing Information

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 Oakrum Pharma, LLC 1-833-597-0413.

About Oakrum Pharma, LLC

Oakrum Pharma, LLC is a privately-owned biopharmaceutical company focusing on development and commercialization of affordable drug therapies. For more information, visit www.oakrumpharma.com.

Forward-looking Statements

Statements in this press release that are not historical facts, including statements about future expectations of Oakrum are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Oakrum intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Oakrum’s actual results to be materially different from its historical results or from any results expressed or implied by said statements. Oakrum’s actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions and the need for regulatory approvals, Oakrum’s ability to fund development of its technology and to successfully complete clinical trials, the length of time and costs required to complete clinical trials and to submit applications for regulatory approvals, products developed by competing companies, commercial acceptance of Oakrum’s products, and other factors. Oakrum is not responsible for updating events occurring after the date of this press release.