Access

Established Brands Preferred Pharmacy Network

Pay No More Than $15/month^*
for eligible commercially insured or cash pay patients

*Subject to eligibility requirements. Established Brands Preferred Pharmacy Network: Available to eligible commercially insured patients only. Patients with government insurance are not eligible, including, but not limited to, patients with Medicare, Medicaid, Medigap, TriCare, VA, DoD, or any other federal-, state-, or government-funded government healthcare program. The maximum financial assistance provided to eligible patients is $3,816 per calendar year. Cash-Discount Direct Program: Cash pay patients may pay no more than $15/mo when filled as a 90-day prescription if eligible. Cannot be used in conjunction with Medicare, Medicaid or other federal or state programs. Patients must agree not to seek reimbursement through insurance including any federal or state program in order to participate in the Cash-Discount Direct Program.

*Full Terms and Conditions

ANI Pharmaceuticals, Inc. (ANI) wants to ensure patients have access to their medication. To do that, ANI has created a variety of options at the pharmacy level designed to help patients have affordable access to their medication. Eligible patients only. Who’s eligible? Keep reading.

Federal or state‐funded programs, including but not limited to Medicaid, Medicare, Department of Veterans Affairs, Department of Defense, or TRICARE do not allow patients to receive any additional discount. Patients whose prescriptions are paid in part or in full by a federal or state-funded program, such as any of the programs listed above, or where otherwise prohibited by law, are not able to participate in either of the programs.

Established Brands Preferred Pharmacy Network: Patients covered through commercial insurance may pay no more than $15 for a 30-day supply of Sovuna at any pharmacy in the Established Brands Preferred Pharmacy Network. Savings are applied automatically at the point of sale with no cards or coupons required. Pharmacies participating in the pharmacy network can be found at SovunaHCQ.com. If the patient chooses to use a retail pharmacy outside of the Established Brands Preferred Pharmacy Network, the patient or pharmacist can acquire a copay card at SovunaHCQ.com to reduce their copay to no more than $15 per 30-day supply. The maximum financial assistance provided to eligible patients is $3,816 per calendar year.

ANI Cash-Discount Direct Program: Any eligible patient with a valid prescription for Sovuna may opt to take advantage of the ANI Cash-Discount Direct Program, which provides patients with access to Sovuna for $15 per 30 days when filled as a 90-day prescription. Patients must certify that they will not submit a claim for reimbursement for Sovuna to any third-party payer, including, but not limited to, any state or federal program and that they will not include any amounts paid for Product in his or her True Out-of-Pocket (“TrOOP”) expenses. If seeking assistance for more than one calendar year, patients will be required to verify eligibility each calendar year.

The Established Brands Preferred Pharmacy Network and Cash-Pay Discount Programs are only available to patients residing in the U.S. (not including Puerto Rico or other U.S. territories)

The Established Brands Preferred Pharmacy Network and Cash-Pay Discount Programs are not health insurance.

These savings programs cannot be combined with any other coupon, cash discount card, certificate, voucher, or similar offer.

ANI reserves the right to modify or cancel this program at any time.

Void if prohibited by law, taxed, or restricted.

For questions about the programs contact ANI Customer Service at 1-800-434-1121.

INDICATIONS AND USAGE

SOVUNA is an antimalarial and antirheumatic indicated for the:

Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients.
Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients.
Treatment of rheumatoid arthritis in adults.
Treatment of systemic lupus erythematosus in adults.
Treatment of chronic discoid lupus erythematosus in adults.

LIMITATIONS OF USE

SOVUNA is not recommended for the:

Treatment of complicated malaria.
Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species.
Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified.
Prophylaxis of malaria in geographic areas where chloroquine resistance occurs.
Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites.
For radical cure of P. vivax or P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: SOVUNA is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds.

WARNINGS AND PRECAUTIONS

Cardiomyopathy and Ventricular Arrhythmias: Fatal and life-threatening cases of cardiotoxicity, including cardiomyopathy, have been reported in patients treated with SOVUNA. Signs and symptoms of cardiac compromise have occurred during acute and chronic SOVUNA treatment. In multiple cases, endomyocardial biopsy showed association of the cardiomyopathy with phospholipidosis in the absence of inflammation, infiltration, or necrosis. Drug-induced phospholipidosis may occur in other organ systems.

Patients may present with ventricular hypertrophy, pulmonary hypertension and conduction disorders including sick sinus syndrome. ECG findings include atrioventricular, right or left bundle branch block.

SOVUNA has a potential to prolong the QT interval. Ventricular arrhythmias (including torsades de pointes) have been reported in SOVUNA-treated patients. The magnitude of QT prolongation may increase with increasing concentrations of the drug. The recommended dose should not be exceeded.

Avoid SOVUNA in patients with congenital or documented acquired QT prolongation and/or known risk factors for prolongation of the QT interval. SOVUNA is not recommended in patients taking other drugs that have the potential to prolong the QT interval. Correct electrolyte imbalances prior to use. Monitor cardiac function as clinically indicated during SOVUNA therapy. Discontinue SOVUNA if cardiotoxicity is suspected or demonstrated by tissue biopsy.

Retinal Toxicity: Irreversible retinal damage was observed in some patients treated with hydroxychloroquine sulfate related to cumulative dosage and treatment duration. Risk factors for retinal damage include daily hydroxychloroquine sulfate dosages ≥5 mg/kg of actual body weight, durations of use greater than five years, renal impairment, use of concomitant drug products such as tamoxifen citrate, and concurrent macular disease. Baseline retinal exam within the first year of treatment and annual exams while the patient is on treatment with SOVUNA are recommended. If ocular toxicity is suspected, discontinue SOVUNA and monitor the patient closely given that retinal changes and visual disturbances may progress even after cessation of therapy.

Serious Skin Reactions: Serious adverse reactions have been reported with the use of SOVUNA including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalized exanthematous pustulosis (AGEP). Monitor for serious skin reactions, especially in patients receiving a drug that may also induce dermatitis. Advise patients to seek medical attention promptly if they experience signs and symptoms of serious skin reactions such as blisters on the skin, eyes, lips or in the mouth, itching or burning, with or without fever. Discontinue SOVUNA if these severe reactions occur.

Worsening of Psoriasis: Administration of SOVUNA to patients with psoriasis may precipitate a severe flare-up of psoriasis. Avoid SOVUNA in patients with psoriasis unless the benefit to the patient outweighs the possible risk.

Risks Associated with Use in Porphyria: Administration of SOVUNA in patients with porphyria may exacerbate porphyria and should be avoided.

Hematologic Toxicity: SOVUNA may cause myelosuppression including aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia. Monitor blood cell counts periodically in patients on prolonged SOVUNA therapy. If the patient develops myelosuppression which cannot be attributable to the disease, discontinue the drug.

Hemolytic Anemia Associated with G6PD Deficiency: Hemolysis has been reported in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Monitor for hemolytic anemia as this can occur, particularly in association with other drugs that cause hemolysis.

Skeletal Muscle Myopathy or Neuropathy: Skeletal muscle myopathy or neuropathy leading to progressive weakness and atrophy of proximal muscle groups, depressed tendon reflexes, and abnormal nerve conduction, have been reported. Muscle and nerve biopsies have shown associated phospholipidosis. Drug-induced phospholipidosis may occur in other organ systems. Assess muscle strength and deep tendon reflexes periodically in patients on long-term therapy with SOVUNA. Discontinue SOVUNA if muscle or nerve toxicity is suspected or demonstrated by tissue biopsy.

Neuropsychiatric Reactions Including Suicidality: Suicidal behavior, suicidal ideation, and other neuropsychiatric adverse reactions have been reported in patients treated with SOVUNA. Advise patients to contact their healthcare provider promptly if they experience new or worsening neuropsychiatric symptoms such as depression, suicidal thoughts or behavior, or mood changes.

Hypoglycemia: SOVUNA can cause severe and potentially life-threatening hypoglycemia, in the presence or absence of antidiabetic agents. Measure blood glucose in patients presenting with clinical symptoms suggestive of hypoglycemia and adjust the antidiabetic treatment as necessary. Warn SOVUNA-treated patients about the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia; diabetic patients should monitor their blood sugar levels. Advise patients to seek medical attention if they develop any signs and symptoms of hypoglycemia.

Renal Toxicity: Proteinuria with or without moderate reduction in glomerular filtration rate have been reported with the use of SOVUNA. Renal biopsy showed phospholipidosis without immune deposits, inflammation, and/or increased cellularity. Physicians should consider phospholipidosis as a possible cause of renal injury in patients with underlying connective tissue disorders who are receiving SOVUNA. Drug-induced phospholipidosis may occur in other organ systems. Discontinue SOVUNA if renal toxicity is suspected or demonstrated by tissue biopsy.

ADVERSE REACTIONS

The most common adverse reactions reported are nausea, vomiting, diarrhea, and abdominal pain.

To report Adverse Reactions you may contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For medical inquiries please call 1-855-204-1431 or email [email protected].

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