PITTSBURGH, Aug. 20, 2024 /PRNewswire/ -- PANTHERx® Rare, a leader in rare disease product patient access and support services in the United States, is pleased to announce it was selected by Upsher-Smith Laboratories, LLC for the distribution of TORPENZ™ (everolimus) Tablets for the treatment of Tuberous Sclerosis Complex (TSC).
TORPENZ™ (everolimus) Tablets are an oral kinase inhibitor FDA approved for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) requiring therapeutic intervention but cannot be curatively resected. In addition, it is approved for the treatment of adults with renal angiomyolipoma and TSC not requiring immediate surgery.
TSC, or Tuberous Sclerosis Complex, is a rare genetic disorder associated with the formation of benign (non-cancerous) tumors affecting various organs. While the tumors are not malignant, they can grow abnormally large and damage the affected organs such as skin, brain, eyes, heart, kidneys, and lungs. SEGA, or subependymal giant cell astrocytoma, is a type of brain tumor in TSC that most commonly grows from childhood to young adulthood and can cause hydrocephalus (a buildup of cerebrospinal fluid in the ventricles of the brain) leading to increased pressure with symptoms of headache, nausea, vomiting, irritability, and behavioral changes. Approximately 80% of individuals with TSC develop seizures, which may manifest as infantile spasms or other focal and generalized seizures later in life. Renal angiomyolipoma, a benign tumor of the kidney, may also develop in individuals with TSC later in childhood or adolescence and are commonly asymptomatic but in some cases may cause flank pain or kidney dysfunction.
“When people have a chronic rare disease, they think about it every day and so do we. We recognize the complex and sometimes frightening nature of such diseases to which our patients and their families are learning to adapt. We look forward to working hard with Upsher-Smith to ease the burden and decrease stress so patients can focus on feeling as healthy as possible,” said Bansi Nagji, CEO of PANTHERx® Rare Pharmacy.
About PANTHERx® Rare
PANTHERx Rare is a dual-accredited specialty pharmacy focused on rare and orphan disease, distributing several orphan products, and providing access and support services to those needing them most. PANTHERx transforms lives by delivering medicine breakthroughs, clinical excellence, and access solutions to people living with rare and devastating conditions. While each rare condition affects few people, together all rare diseases impact an estimated 25 to 30 million Americans. Currently over 7,000 rare diseases have been identified and more than 90% of rare diseases are still without an FDA-approved treatment. Changes in federal policy and advances in science have led to a surge in FDA orphan drug approvals, providing tremendous hope to the rare disease community.
PANTHERx is a dual-accredited specialty pharmacy, holding distinctions in rare disease including the Accreditation Commission for Health Care (ACHC) Distinction in Orphan Drugs and Utilization Review Accreditation Commission (URAC) Rare Disease Center of Excellence. As a pharmacy focused on patient satisfaction, PANTHERx is now a six-time winner of the prestigious MMIT Patient Choice Award, including the 2023 honor. PANTHERx is headquartered in Pittsburgh, Pennsylvania and is licensed in all 50 states and US territories.
Please see Important Safety Information at the end of this communication and visit TORPENZ.com for full Prescribing Information.
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.
TORPENZ is a trademark of Upsher-Smith Laboratories, LLC.
All other marks are property of their respective owners.
For more information, please contact marketing@pantherxrare.com
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