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Resources

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Resources

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IBSA Direct enables patients with or without health insurance to purchase their IBSA medicine through our network of participating specialty pharmacies and have it delivered to their home. IBSA medicines ordered by e-prescription or fax and the process is fast and easy. For more details, contact a participating IBSA Direct pharmacy.

Easy access
Transparent
pricing
Flexible supply
Available doses
and fast delivery
logo: Highland Specialty Pharmacy

Ships to all 50 states

PHONE (toll free): 855-894-4441
PHONE (local): 601-268-6033

Contact now

Information for Prescribers

Prescriber Order Form

Self/Cash Pay patients may pay as low as $50 for a 30–day or $150 for a 90–day supply with the Renewal Program through IBSA Direct. Terms, conditions and eligibility restrictions apply.

logo: Sterling Specialty Pharmacy

Ships to all 50 states
and Puerto Rico

PHONE (toll free): 888-618-4126

Contact now

Information for Prescribers

Prescriber Order Form

Self/Cash Pay patients may pay as low as $50 for a 30–day or $150 for a 90–day supply with the Renewal Program through IBSA Direct. Terms, conditions and eligibility restrictions apply.

Downloadable resources to assist with patient access

Patient Access Resource Guide

Includes letters and forms to help with Prior Authorization (PA) and ensure patient access to TIROSINT and TIROSINT-SOL

Download

Specialty Pharmacy Patient Start Form

To help expedite the Specialty Pharmacy application process

Download

Sample Letter of Medical Necessity

For use when a patient’s coverage has been denied by their health insurer

Download

Sample Letter of Appeal

For use when a patient’s PA request is denied by their health insurer (may require a Letter of Medical Necessity)

Download

Sample Formulary Exception Request Letter

For use when either TIROSINT or TIROSINT-SOL are not on a health plan’s formulary (may require a Letter of Medical Necessity)

Download

Sample Formulary Tiering Exception Request Letter

For use when either TIROSINT or TIROSINT-SOL are placed in a nonpreferred tier (may require a Letter of Medical Necessity and your patient to submit a Statement of Financial Hardship)

Download

Downloadable resources for patients

icon: booklet

Getting Started Brochure

Patients can learn what to expect from TIROSINT and ensure they start treatment in the best way possible.

Download now

TIROSINT Tips Sheet

Give your patients access to tips to help them get the most from treatment by establishing a routine.

Download now

Copay Savings Card*

Patients can get instant savings on their TIROSINT prescription using the TIROSINT Copay Card at any retail pharmacy.

Download now

*Subject to eligibility. Individual out of pocket costs may vary. Not valid for prescriptions eligible to be reimbursed under Medicare (including Medicare Part D and Medicare Advantage), Medicaid, TRICARE®, CHAMPUS, the Puerto Rico Governmental Health Insurance Plan, or other federal, state, or governmental healthcare programs. Valid in the U.S. only. Accepted by participating pharmacies only. Limitations may apply to Massachusetts and California residents. This Savings Card Program is not insurance. Follow the dosage instructions given by the doctor. This card may not be redeemed for cash. Cardholders with questions, please call (312) 913-6886. IBSA Pharma Inc. reserves the right to rescind, revoke, or amend this offer. Not valid if reproduced. Void where prohibited by law. The TIROSINT® Savings Card cannot be combined with any other coupon, free trial, discount, prescription savings card or any other offer. Maximum benefit applies.

Patient Instructions for an Eligible Commercially Insured Patient: In order to redeem this card you must have a valid prescription for at least a 30-day quantity of TIROSINT® (levothyroxine sodium) capsules or TIROSINT®-SOL (levothyroxine sodium) oral solution.

1-Month Supply – Eligible commercially insured patients will be responsible for paying the first $25 for a 30-day quantity and any copay amount not covered by the card. Maximum benefit applies.

3-Month Supply – Eligible commercially insured patients will be responsible for the first $60 for a 90-day quantity and any copay amount not covered by the card. Maximum benefit applies.

Pharmacist Instructions for a Patient With an Eligible Commercial Third Party Payer: Submit the claim to the primary Commercial Third Party Payer first, then submit the balance due to PDMI as a Secondary Payer COB (coordination of benefits) with patient responsibility amount and a valid Other Coverage Code, (e.g., 8 or 3). Maximum benefit applies. Reimbursement will be received from PDMI. For any questions regarding PDMI online processing, please call the Help Desk at 1-316-219-4802.

Patient Instructions for Uninsured Patients: In order to redeem this card you must have a valid prescription for at least a 30-day quantity of TIROSINT® (levothyroxine sodium) capsules or TIROSINT®-SOL (levothyroxine sodium) oral solution.

1-Month Supply – Eligible uninsured patients will be responsible for paying the first $25 for a 30-day quantity and any amount not covered by the card. Maximum benefit applies.

3-Month Supply – Eligible uninsured patients will be responsible for the first $60 for a 90-day quantity and any amount not covered by the card. Maximum benefit applies.

Pharmacist Instructions for Uninsured Patients: Submit this claim to PDMI. A valid Other Coverage Code (e.g., 1) is required for uninsured patients. The patient is responsible for the first $25 (30-day quantity prescription) or $60 (90-day quantity prescription) and the remaining amount that is not covered by the card. Valid Other Coverage Code required. Maximum benefit applies. Reimbursement will be received from PDMI. For any questions regarding PDMI online processing, please call the Help Desk at 1-316-219-4802.

INDICATION AND USAGE

TIROSINT is L-thyroxine (T4) indicated for adults and pediatric patients 6 years and older with:

  • Hypothyroidism – As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.
  • Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression – As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

Limitations of Use:

  • TIROSINT is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients.
  • TIROSINT is not indicated for treatment of transient hypothyroidism during the recovery phase of subacute thyroiditis.

IMPORTANT SAFETY INFORMATION

WARNING: NOT FOR THE TREATMENT OF OBESITY OR FOR WEIGHT LOSS

  • Thyroid hormones, including TIROSINT, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss.
  •  In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction.
  • Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.

Contraindications

  • TIROSINT is contraindicated in patients with uncorrected adrenal insufficiency.

Warnings and Precautions 

  • Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease: Initiate TIROSINT at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including atrial fibrillation.
  • Myxedema coma: Do not use oral thyroid hormone drug products to treat myxedema coma.
  • Acute adrenal crisis in patients with concomitant adrenal insufficiency: Treat with replacement glucocorticoids prior to initiation of TIROSINT treatment.
  • Prevention of hyperthyroidism or incomplete treatment of hypothyroidism: Proper dose titration and careful monitoring is critical to prevent the persistence of hypothyroidism or the development of hyperthyroidism.
  • Worsening of diabetic control: Therapy in patients with diabetes mellitus may worsen glycemic control and result in increased
    antidiabetic agent or insulin requirements. Carefully monitor glycemic control after starting, changing, or discontinuing thyroid hormone therapy.
  • Decreased bone mineral density associated with thyroid hormone over-replacement: Over-replacement can increase bone reabsorption and decrease bone mineral density. Give the lowest effective dose.

Adverse Reactions 

Adverse reactions with levothyroxine therapy are primarily those of hyperthyroidism due to therapeutic overdosage. They include the following:

  • General: fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating
  • Central Nervous System: headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia
  • Musculoskeletal: tremors, muscle weakness, muscle spasm
  • Cardiovascular: palpitations, tachycardia, arrythmias, increased pulse and blood pressure, heart failure, angina, myocardial
    infarction, cardiac arrest
  • Respiratory: dyspnea
  • Gastrointestinal (GI): diarrhea, vomiting, abdominal cramps, elevations in liver function tests
  • Dermatologic: hair loss, flushing, rash
  • Endocrine: decreased bone mineral density
  • Reproductive: menstrual irregularities, impaired fertility

Adverse Reactions in Children

Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in children receiving levothyroxine therapy. Overtreatment may result in craniosynostosis in infants and premature closure of the epiphyses in children with resultant compromised adult height. Seizures have been reported rarely with the institution of levothyroxine therapy.

Hypersensitivity Reactions

Hypersensitivity reactions to inactive ingredients (in this product or other levothyroxine products) have occurred in patients treated with thyroid hormone products. These include urticaria, pruritis, skin rash, flushing, angioedema, various GI symptoms (abdominal pain, nausea, vomiting and diarrhea), fever, arthralgia, serum sickness and wheezing. Hypersensitivity to levothyroxine itself is not known to occur.

Drug Interactions

Many drugs and some foods can exert effects on thyroid hormone pharmacokinetics (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to TIROSINT. Administer at least 4 hours before or after drugs that are known to interfere with absorption. See full prescribing information for drugs that affect thyroid hormone pharmacokinetics and metabolism.

Please click here for Full Prescribing Information, including BOXED WARNING, for TIROSINT.

ATA=American Thyroid Association; LT4=levothyroxine; TSH=thyroid-stimulating hormone.
References: 1. Jonklaas J, Bianco AC, Bauer AJ, et al. Guidelines for the treatment of hypothyroidism: prepared by the American Thyroid Association Task Force on Thyroid Hormone Replacement. Thyroid. 2014;24(12):1670-1751. doi:10.1089/thy.2014.0028 2. TIROSINT. Prescribing information. Institut Biochimique SA (IBSA); 2022.
HCP=healthcare professional.
LT4=levothyroxine; T4=thyroxine; TSH=thyroid-stimulating hormone.
References: 1. TIROSINT. Prescribing information. Institut Biochimique SA (IBSA); 2022. 2. Data on file, Institut Biochimique SA (IBSA).
LT4=levothyroxine; TSH=thyroid-stimulating hormone.
T4=thyroxine; TSH=thyroid-stimulating hormone.
TSH=thyroid-stimulating hormone.
TSH=thyroid-stimulating hormone.
References: 1. Jonklaas J, Bianco AC, Bauer AJ, et al. Guidelines for the treatment of hypothyroidism: prepared by the American Thyroid Association Task Force on Thyroid Hormone Replacement. Thyroid. 2014;24(12):1670-1751. doi:10.1089/thy.2014.0028 2. TIROSINT. Prescribing information. Institut Biochimique SA (IBSA); 2022.