YARAL Pharma Reaffirms Commitment to Pharmacists at 2024 NCPA Annual Convention and Expo

YARAL Pharma Reaffirms Commitment to Pharmacists at 2024 NCPA Annual Convention and Expo

YARAL Pharma underscored its dedication to supporting pharmacists during this year’s National Community Pharmacists Association (NCPA) Annual Convention and Expo in Columbus, Ohio, which took place from October 26-29.

Since its founding, YARAL Pharma has been committed to building strong relationships with pharmacists, prioritizing their insights and understanding their needs. This theme continued throughout the meeting, where the Company engaged in meaningful conversations with attendees and collaborated with the Pharmacy Podcast Network and Mark Garofoli, PharmD., also known as “Pain Guy”.

YARAL Pharma recently extended its association with The Pharmacy Podcast Network (PPN), a leading platform for pharmacy professionals whose mission is to support, educate, and amplify the voices of the entire pharmacy profession and impact their delivery of the highest of quality patient-centered care.

At its booth, YARAL Pharma featured its product line, including Levothyroxine Sodium Capsules for hypothyroidism and Diclofenac Epolamine 1.3%, topical patches for the management of acute pain due to strains, sprains and contusions. Members of the team shared its exclusive supplier status for authorized generic Levothyroxine Sodium Capsules in the U.S. and highlighted the product’s key attributes. Available in twelve dosage strengths, these capsules are formulated with tolerability in mind, and include only four ingredients: levothyroxine, gelatin, glycerin, and water.¹

Attendees were also drawn to the booth to listen in as Dr. Garofoli and YARAL Pharma CEO Stephen Beckman recorded a podcast discussing pain management and the importance of non-opioid options. Their conversation highlighted the role of topical patches in managing acute pain, and YARAL’s commitment to providing high-quality authorized generics and complex generic medicines that use innovative technologies. The following day, Stephen Beckman continued the conversation with PPN host Todd Eury and discussed YARAL Pharma’s contributions to the generics industry.

YARAL Pharma CEO Stephen Beckman commented, “At YARAL, we are redefining how we engage with our customers, and this is exemplified by our partnership with the Pharmacy Podcast Network. Listening to the needs of pharmacists is our top priority, allowing us to support patient care by focusing on quality, continuity of supply, and exceptional customer service.”

The team ended a successful NCPA 2024 with a photo in the YARAL-sponsored photo booth and looks forward to continuing conversations with pharmacists in the coming year.

For Full Prescribing Information, including Important Safety Information and Boxed Warning for Levothyroxine Sodium Capsules, visit: www.yaralpharma.com/levothyroxine-pi.

For Full Prescribing Information including Important Safety Information and Boxed Warning for Diclofenac Epolamine 1.3% Topical System, visit: www.yaralpharma.com/diclofenac-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.

Levothyroxine Sodium Capsules

IMPORTANT SAFETY INFORMATION

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.

Diclofenac Epolamine 1.3% Topical System

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

Diclofenac epolamine topical system 1.3% contains diclofenac epolamine, which is a nonsteroidal anti-inflammatory drug (NSAID), and is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.

CONTRAINDICATIONS
Diclofenac epolamine topical system 1.3% is contraindicated in the following patients:

• Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product.
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
  Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients in the setting of coronary artery bypass graft (CABG) surgery.
• On non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczema, infected lesions, burns or wounds.

WARNINGS AND PRECAUTIONS

• Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop
• Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure
• Heart Failure and Edema: Avoid use of diclofenac epolamine topical system 1.3% in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure
• Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of diclofenac epolamine topical system 1.3% in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function
• Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs
• Exacerbation of Asthma Related to Aspirin Sensitivity: Diclofenac epolamine topical system 1.3% is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity)
• Serious Skin Reactions: Discontinue diclofenac epolamine topical system 1.3% at first appearance of skin rash or other signs of hypersensitivity
• Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnant women starting at 30 weeks gestation
• Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia

ADVERSE REACTIONS
Most common adverse reactions for diclofenac epolamine topical system 1.3% are application site pruritus and other application site reactions.

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.

Please see Full Prescribing Information, including Boxed Warning, at www.yaralpharma.com/diclofenac-pi.

About YARAL Pharma
YARAL Pharma Inc. (Parsippany, NJ) is the US 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 US 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

1. Levothyroxine Sodium Capsules [package insert]. Parsippany, NJ: YARAL Pharma Inc; 2021.

Media Contact
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Kovak-Likly Communications
dbasile@klcpr.com

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