Upsher-Smith Expands Rare Disease Portfolio with Launch of Torpenz^™ (everolimus) Tablets

Maple Grove, MN – August 5, 2024 – Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the recent launch of TORPENZ™ (everolimus) Tablets in 2.5 mg, 5 mg, 7.5 mg and 10 mg strengths. TORPENZ™ is an oral mTOR inhibitor used in patients with Tuberous Sclerosis Complex (TSC). Upsher-Smith’s TORPENZ™ (everolimus) Tablets are indicated for the treatment of adult patients with renal angiomyolipoma and TSC, not requiring immediate surgery and is also indicated in adult and pediatric patients aged 1 year and older with TSC for the treatment of subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected.

“As our specialty product portfolio continues to grow, Upsher-Smith remains committed to understanding the unique needs of rare disease communities and providing value-added services that ease access to critical medications,” said Jim Maahs, Vice President, Specialty & Rare Disease. “TORPENZ™ is the only everolimus backed our Promise of Support™ Program – a patient-centered initiative designed to offer patients, caregivers, and healthcare providers in the rare disease community comprehensive support throughout the treatment journey.”

The Upsher-Smith Promise of Support™ Program ensures timely and reliable access to specialty medications through customized services such bridge and starter medication supply.

Through its partnership with specialty pharmacy, PANTHERx® Rare, Upsher-Smith commits to providing a best-in-class experience for patients requiring rare disease medications, responding with urgency, and maintaining clear, open communication. It also includes copay assistance for eligible patients to help lessen the financial burden on patients and their families. To learn more about TORPENZ™ and the Upsher-Smith Promise of Support™ Program, visit www.torpenz.com.

Product Information

Product	Strength	NDC #	Package Sizes
TORPENZ™ (everolimus) Tablets	2.5 mg	0245-0822-30	30-Count Bottles
TORPENZ™ (everolimus) Tablets	5 mg	0245-0823-30	30-Count Bottles
TORPENZ™ (everolimus) Tablets	7.5 mg	0245-0824-30	30-Count Bottles
TORPENZ™ (everolimus) Tablets	10 mg	0245-0825-30	30-Count Bottles

For questions about ordering, please call Upsher-Smith at 1-800-654-2299.

Please refer to the full Prescribing Information for TORPENZ™ (everolimus) Tablets, USP here. You can also call 1-888-650-3789 to obtain a copy of the full Prescribing Information. You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC at 1-855-899-9180 or to the FDA by visiting www.fda.gov/medwatch.

WHAT IMPORTANT SAFETY INFORMATION SHOULD I KNOW ABOUT TORPENZ™ (everolimus) TABLETS in Tuberous Sclerosis Complex?

Do not take TORPENZ if you have had an allergic reaction to everolimus. Talk to your healthcare provider before taking TORPENZ if you are allergic to sirolimus or temsirolimus. Ask your provider if you do not know.

TORPENZ can cause serious side effects, including:

• Lung or breathing problems. In some people, these may be severe and can be life threatening. Tell your healthcare provider right away if you have new or worsening cough, shortness of breath, chest pain, difficulty breathing or wheezing.
• Higher likelihood of infection such as pneumonia, or a bacterial, fungal, or viral infection. Viral infections may include active hepatitis B in people who have had hepatitis B in the past (reactivation). In some adults and children, these infections may be severe and can be life threatening. You may need to be treated as soon as possible. Tell your healthcare provider right away if you have a temperature of 100.5˚F or above, chills, or do not feel well. Symptoms of infection may include:
  • Fever
  • Chills
  • Skin rash
  • Joint pain and swelling
  • Tiredness
  • Loss of appetite
  • Nausea
  • Pale stools or dark urine
  • Yellowing of the skin
  • Pain in the upper right side of the stomach
• Severe allergic reactions. Get medical help right away if you have signs of an allergic reaction, including rash, itching, hives, flushing, trouble breathing or swallowing, chest pain or dizziness.
• Possible increased risk for a type of allergic reaction called angioedema in people who take an Angiotensin-Converting Enzyme (ACE) inhibitor with TORPENZ. Talk with your healthcare provider before taking TORPENZ if you are not sure if you take an ACE inhibitor. Get medical help right away if you have trouble breathing or develop swelling of your tongue, mouth, or throat during treatment with TORPENZ.
• Mouth ulcers and sores. Mouth ulcers and sores are common during treatment with TORPENZ but can also be severe. When you start TORPENZ, your healthcare provider may tell you to also start a prescription mouthwash to reduce the likelihood of getting mouth ulcers or sores and to reduce their severity. Follow your provider’s instructions on how to use this mouthwash. If you develop pain, discomfort, or open sores in your mouth, tell your provider.
• Kidney failure. In some people, this may be severe and can be life threatening. Your healthcare provider should check your kidney function before and during treatment.
• Wound healing problems. Wounds may not heal properly during TORPENZ treatment. Tell your healthcare provider if you plan to have any surgery before starting or during treatment. You should stop TORPENZ at least 1 week before planned surgery. Your provider should tell you when to start taking TORPENZ again after surgery.
• Increased blood sugar and fat (cholesterol and triglyceride) levels in the blood. Your healthcare provider should check your fasting blood sugar, cholesterol, and triglyceride levels in the blood before you start and during treatment.
• Decreased blood cell counts. TORPENZ can cause you to have decreased red blood cells, white blood cells and platelets. Your healthcare provider should check your blood cell counts before you start and during treatment.
• Worsening side effects from radiation treatment that can sometimes be severe. Tell your healthcare provider if you have had or are planning to receive radiation therapy.

Before taking TORPENZ, tell your healthcare provider about all of your medical conditions, including if you:

• Have or have had kidney or liver problems, have diabetes or high blood sugar, have high blood cholesterol, have any infections, or previously had hepatitis B.
• Are scheduled to receive any vaccinations. You should not receive a “live vaccine” or be around people who have recently received a “live vaccine” during your treatment with TORPENZ. If you are not sure about the type of immunization or vaccine, ask your provider. For children, work with your provider to complete the recommended childhood series of vaccines before your child starts TORPENZ.
• Are pregnant, can become pregnant, or have a partner who can become pregnant. TORPENZ can cause harm to your unborn baby. For females who are able to become pregnant, your provider will give you a pregnancy test before you start TORPENZ. Use effective birth control during treatment and for 8 weeks after your last dose of TORPENZ. Males with a female partner should use effective birth control during treatment and for 4 weeks after your last dose of TORPENZ.
• Are breastfeeding or plan to breastfeed. Do not breastfeed during treatment and for 2 weeks after your last dose of TORPENZ.
• Are planning to have or have had a recent surgery. You should stop taking TORPENZ at least 1 week before planned surgery.
• Have received or are planning to receive radiation therapy.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking TORPENZ with some medicines can cause serious side effects. Keep a list of medications you take, and show it to your healthcare provider and pharmacist when you get a new medicine. Especially tell your provider if you take:

• St. John’s Wort (Hypericum perforatum)
• Medicine for fungal or bacterial infections, tuberculosis, seizures, HIV-AIDS, heart conditions or high blood pressure, including ACE inhibitors
• Medicines that weaken your immune system (your body’s ability to fight infections and other problems)

Ask your provider or pharmacist if you are not sure if your medicine is one of those taken for the conditions listed above. If you are taking any medicines for the conditions listed above, your provider might need to prescribe a different medicine or your dose of TORPENZ may need to be changed. Tell your provider before you start any new medicine.

You should not drink grapefruit juice or eat grapefruit during your treatment with TORPENZ. It may make the amount of TORPENZ in your blood increase to a harmful level.

The most common side effect of TORPENZ in people who have SEGA or renal angiomyolipoma include respiratory tract infection.

Other side effects that may occur with TORPENZ:

• Absence of menstrual periods (menstruation). Tell your healthcare provider if this happens.
• TORPENZ may affect fertility and may affect your ability to become pregnant if you are female or your ability to father a child if you are male. Talk to your provider if this is a concern.

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of TORPENZ. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You can also visit TORPENZ.com, upsher-smith.com or call 1-888-650-3789.

You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch or call 1-800-332-1088.

WHAT ARE TORPENZ (everolimus) TABLETS?

TORPENZ is a prescription medicine used to treat the following types of benign (non-cancerous) tumors that are seen with a genetic condition called tuberous sclerosis complex (TSC):

• Brain tumors called subependymal giant cell astrocytoma (SEGA), when the tumor cannot be removed completely by surgery, in adults and children 1 year and older.
• Kidney tumors called angiomyolipoma, when the tumor does not require surgery right away, in adults.

For additional information, including safety information, for non-TSC indications, see the full Prescribing Information, including Patient Information.

About Tuberous Sclerosis Complex

Tuberous Sclerosis Complex (TSC) is a rare genetic disease that causes non-cancerous (benign) tumors to grow in the brain and several areas of the body, including the spinal cord, nerves, eyes, lung, heart, kidneys, and skin. Nearly one million people worldwide are estimated to be living with TSC, with approximately 50,000 in the United States.

About Upsher-Smith

Upsher-Smith Laboratories, LLC, now a member of Bora Group, is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. We bring generics and brands to a wide array of customers, always backed by our attentive level of service, strong industry relationships, and dedication to uninterrupted supply. For more information, visit upshersmith02.wpengine.com.

About Bora

Founded in 2007, Bora Pharmaceutical Co., Ltd. (“Bora” or “the Company”, 6472.TW) now is the largest pharmaceutical manufacturer in Taiwan with well-connected global distribution to supply more than 100 countries around the world. Headquartered in Taiwan, Bora has dedicated itself to becoming a global leader in pharmaceutical manufacturing by offering its clients the best quality, efficiency and reliability.

TORPENZ and PROMISE OF SUPPORT are trademarks of Upsher-Smith Laboratories, LLC.