MAPLE
GROVE, Minn., Aug. 5, 2024
/PRNewswire/ -- 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:
o
Fever
o
Chills
o Skin
rash
o Joint
pain and swelling
o
Tiredness
|
o Loss of
appetite
o
Nausea
o Pale
stools or dark urine
o
Yellowing of the skin
o 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 www.upsher-smith.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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/upsher-smith-expands-rare-disease-portfolio-with-launch-of-torpenz-everolimus-tablets-302214621.html
SOURCE Upsher-Smith Laboratories