YARAL Pharma Inc. (YARAL Pharma), the U.S. generics subsidiary
of IBSA (Institut Biochimique SA), a multinational pharmaceutical
company headquartered in Lugano, Switzerland, today announced that
they are now the exclusive supplier of the authorized generic
levothyroxine sodium capsules in the United States. Levothyroxine
Sodium Capsules are used to treat hypothyroidism.
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Levothyroxine Sodium Capsules. (Photo:
YARAL Pharma Inc.)
“When it comes to managing hypothyroidism, not all levothyroxine
medications are created equal,” said Stephen Beckman, CEO of YARAL
Pharma. “Each year, millions of patients are treated with
levothyroxine. For those who have trouble tolerating traditional
levothyroxine tablets, the answer may lie in the dosage form. YARAL
is pleased to offer patients a high-quality gel capsule product,
specially formulated to improve the tolerability of LT4 therapy,
supported by continuity of supply, and an exceptional level of
customer service.”
YARAL Pharma’s Levothyroxine Sodium Capsules, a unique gel-cap
formulation designed to address concerns of absorption and
tolerability commonly found in levothyroxine tablets are available
in twelve dosage strengths. The capsules contain only four simple
ingredients: levothyroxine, gelatin, glycerin and water, and are
free from sugars, dyes, alcohol, wheat starch (gluten), and
lactose.1 This is especially important for patients with
hypothyroidism who have allergies or sensitivities to ingredients
commonly found in levothyroxine tablets or for those with certain
gastrointestinal conditions.2
To order YARAL Pharma’s Levothyroxine Sodium Capsules, click
here or contact YARAL Pharma customer service at 866-218-9009.
For Full Prescribing Information, including Boxed Warning,
visit www.yaralpharma.com/levothyroxine-pi.
To report SUSPECTED ADVERSE REACTIONS, contact YARAL Pharma
Inc. at 866-218-9009 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
IMPORTANT SAFETY INFORMATION
WARNING: NOT FOR THE TREATMENT
OF OBESITY OR FOR WEIGHT LOSS
- Thyroid hormones, including Levothyroxine Sodium Capsules,
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.
INDICATIONS AND USAGE
Hypothyroidism primary (thyroidal). Secondary Levothyroxine
Sodium Capsules is indicated as a replacement therapy in adults and
pediatric patients 6 years and older with (pituitary), and tertiary
(hypothalamic) congenital or acquired hypothyroidism.
Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH)
Suppression Levothyroxine Sodium Capsules is indicated as an
adjunct to surgery and radioiodine therapy in the management of
adults and pediatric patients 6 years and older with
thyrotropin-dependent well-differentiated thyroid cancer.
CONTRAINDICATIONS
- Uncorrected adrenal insufficiency
WARNINGS AND PRECAUTIONS
- Cardiac adverse reactions in the elderly and in patients with
underlying cardiovascular disease. Initiate Levothyroxine Sodium
Capsules, 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 Levothyroxine Sodium Capsules, 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.
- Use for the suppression of nontoxic diffuse goiter or nodular
thyroid disease: Use is not recommended in iodine-insufficient
patients.
LIMITATIONS OF USE
- Not indicated for suppression of benign thyroid nodules and
nontoxic diffuse goiter in iodine-sufficient patients,
- Not indicated for treatment of transient hypothyroidism during
the recovery phase of subacute thyroiditis.
ADVERSE REACTIONS
Common adverse reactions with levothyroxine therapy are
primarily those of hypothyroidism 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
- Cardiovascular: palpitations, tachycardia, arrhythmias,
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
- 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.
For Full Prescribing Information, including Boxed Warning,
visit www.yaralpharma.com/levothyroxine-pi.
To report SUSPECTED ADVERSE REACTIONS, contact YARAL Pharma
Inc. at 866-218-9009 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
About YARAL Pharma
YARAL Pharma Inc. (Parsippany, N.J.) is the U.S. generics
subsidiary of IBSA, a global pharmaceutical company headquartered
in Switzerland. By focusing on people and innovating the ways
they’re cared for, YARAL Pharma is proud to offer the same values
and expertise of its parent company to the U.S. market. Dedicated
to ensuring access to affordable authorized generics (AGs) and
complex generic medicines that enhance healthcare outcomes, YARAL
Pharma offers its customers high-quality products across a range of
therapeutic areas, continuity of supply, and a commitment to
exceptional customer service. For more information, visit
www.yaralpharma.com or contact info@yaralpharma.com or
866-218-9009.
About IBSA
IBSA (Institut Biochimique SA) is a Swiss multinational
pharmaceutical Company, founded in 1945 in Lugano. Today, its
products are present in over 90 Countries on 5 continents, through
the Company’s 18 subsidiaries located in Europe, China, and the
United States. The company has a consolidated turnover of 900
million CHF, and employs over 2,200 people between headquarters,
subsidiaries and production sites. IBSA holds 90 families of
approved patents, plus others under development, as well as a vast
portfolio of products, covering 10 therapeutic areas: reproductive
medicine, endocrinology, pain and inflammation, osteoarticular,
aesthetic medicine, dermatology, uro-gynaecology, cardiometabolic,
respiratory, consumer health. It is also one of the largest
operators worldwide in the area of reproductive medicine, and one
of the world’s leaders in hyaluronic acid-based products. IBSA has
based its philosophy on four pillars: Person, Innovation, Quality
and Responsibility.
References
- Levothyroxine Sodium Capsules [package insert]. Parsippany, NJ:
YARAL Pharma Inc; 2021.
- McMillan M, Rotenberg KS, Vora K, et al. Comorbidities,
concomitant medications, and diet as factors affecting
levothyroxine therapy; results of the CONTROL Surveillance Project.
Drugs in R&D. 2015;16(1):53-68.
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