SELECT IMPORTANT SAFETY INFORMATION
- Do not take Orenitram if you have severe liver problems.
- Continuous intravenous (IV) infusions of Remodulin delivered using an external infusion pump, with
a tube placed in a central vein within the chest, are associated with the risk of blood stream infections and
sepsis, which may be fatal. Therefore, continuous subcutaneous (SC) infusion delivered just beneath the skin is
the preferred type of delivery.
-
ADCIRCA is a type of medication called a phosphodiesterase 5 inhibitor (PDE-5i). PDE-5’s can cause blood vessels to widen, which may result in a decrease in blood pressure. If you have heart-disease or any problems with low blood pressure, tell your healthcare provider before taking ADCIRCA, as these conditions may be affected by the action of ADCIRCA.
- Before you take TYVASO or TYVASO DPI, tell your healthcare provider about all of your medical
conditions, including if you have low blood pressure or have had bleeding problems.
Treatment options for adult patients with pulmonary arterial hypertension
(PAH; WHO Group 1), which is high blood pressure in the arteries of your
lungs. TYVASO and TYVASO DPI are also indicated for adult patients with
pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO
Group 3).
Please see below for Indication, additional Important Safety Information, and
links to the Full Prescribing Information for
Orenitram,
Remodulin,
ADCIRCA,
TYVASO, and
TYVASO DPI.
What is Orenitram?
Orenitram is a prescription medicine used to treat pulmonary arterial
hypertension (PAH) which is high blood pressure in the arteries of your lungs.
Orenitram can help slow down the progression of your disease and improve your
ability to exercise. It is not known if Orenitram is safe and effective in
children.
IMPORTANT SAFETY INFORMATION FOR ORENITRAM
Who should not take Orenitram?
Do not take Orenitram if you have severe liver problems.
What should I tell my healthcare provider before taking Orenitram?
Tell your healthcare provider:
- If you have liver problems or diverticulosis.
-
If you are pregnant, breastfeeding, and/or plan to become pregnant or
breastfeed. It is not known if Orenitram will harm your unborn baby or if
Orenitram passes into your breast milk. Talk to your healthcare provider
about the best way to feed your baby during treatment with Orenitram.
-
About all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal
supplements. Orenitram and other medicines may affect each other causing
side effects. Do not start any new medicine until you check with your
healthcare provider. Especially tell your healthcare provider if you take
another medicine that contains treprostinil, such as Remodulin®
or Tyvaso®.
How should I take Orenitram?
-
Do not change your dose or suddenly stop taking Orenitram without first
talking to your healthcare provider.
-
Orenitram is usually taken 3 times a day (about every 8 hours) or 2 times a
day (about every 12 hours). Your healthcare provider will tell you how often
you should take Orenitram. If you have side effects, your healthcare
provider may tell you to change your dose or when you take Orenitram. Take
Orenitram with food.
-
Swallow Orenitram tablets whole. Do not split, chew, crush, or break your
Orenitram tablets. Do not take Orenitram tablets that are damaged or broken.
If Orenitram tablets are not taken whole, they may release too much
medicine at one time. This can lead to side effects.
-
If you miss your dose of Orenitram, take the missed dose as soon as possible
with food.
-
If you miss 2 or more doses of Orenitram, call your healthcare provider to
see if you need to change your dose.
-
If you take too much Orenitram, call your healthcare provider or go to the
nearest hospital emergency room right away.
-
You may see the tablet shell in your stools (bowel movements). This is
usually normal. The tablet shell is not digested. If you have
diverticulosis, the tablet shell may get stuck in a blind pouch or
diverticulum in your intestine.
What are the possible side effects of Orenitram?
Orenitram can cause serious side effects, including worsening of PAH symptoms.
-
Stopping Orenitram suddenly may cause worsening of your PAH symptoms.
Do not change your dose or suddenly stop taking Orenitram without first
talking to your healthcare provider.
-
The most common side effects of Orenitram include
headache, diarrhea, nausea, vomiting, flushing, and pain in arms, legs, and
jaw. These are not all of the possible side effects of Orenitram. Tell your
healthcare provider if you have any side effect that bothers you or does not
go away.
-
Call your healthcare provider for medical advice about side effects. You may
report side effects to the FDA at
www.fda.gov/MedWatch
or call 1-800-FDA-1088.
The risk information provided here is not comprehensive. To learn more about
Orenitram, talk with your healthcare provider. Please see
Full Prescribing Information
and
Patient Information
at
www.orenitram.com
or call Customer Service at 1-877-UNITHER (1-877-864-8437).
OREISIconOCT19
What is Remodulin?
Remodulin is a prescription medication used to treat adults with pulmonary
arterial hypertension (PAH; WHO Group 1), which is high blood pressure in the
arteries of your lungs. Remodulin can reduce symptoms associated with
exercise. Remodulin was studied mainly in patients with NYHA Functional Class
II-IV symptoms. It is not known if Remodulin issafe and effective in children.
In people with PAH who need to switch from epoprostenol, Remodulin is approved
to slow the worsening of symptoms.
IMPORTANT SAFETY INFORMATION FOR REMODULIN
Before you take Remodulin, tell your healthcare provider if you:
-
Have other medical conditions or take other medicines that may affect your
use of Remodulin by increasing the risk of side effects or decreasing the
drug’s effectiveness.
-
Have liver or kidney problems. Your Remodulin dose may need to be adjusted
if you have liver problems.
- Have low blood pressure or bleeding problems.
-
Are taking gemfibrozil (for high cholesterol), rifampin (for infection) or
other drugs that affect liver enzymes. Your doctor may need to adjust your
Remodulin dosage.
-
Are pregnant, breastfeeding, or planning to become pregnant. It is not known
if Remodulin will harm your unborn baby or if Remodulin passes into your
breast milk.
What are the serious side effects of Remodulin?
-
Continuous intravenous (IV) infusions of Remodulin delivered using an
external infusion pump, with a tube placed in a central vein within the
chest, are associated with the risk of blood stream infections and sepsis,
which may be fatal. Therefore, continuous subcutaneous (SC) infusion
delivered just beneath the skin is the preferred type of delivery.
-
Worsening of PAH symptoms. Do not stop taking or greatly reduce your
Remodulin dose without consulting your doctor.
-
Low blood pressure (symptomatic hypotension). If you have low blood pressure
or are taking drugs that lower your blood pressure, the risk of low blood
pressure is increased.
-
Bleeding problems. Remodulin may increase the risk of bleeding in people who
take blood thinners (anticoagulants).
What are the possible side effects of Remodulin?
-
In clinical studies of SC infusion of Remodulin, most people experienced
infusion site pain and infusion site reaction (redness, swelling, and rash).
These symptoms were sometimes severe and sometimes required treatment with
narcotics or discontinuation of Remodulin.
-
IV infusion of Remodulin delivered through an external pump has been
associated with the risk of blood stream infections, arm swelling, tingling
sensations, bruising, and pain.
-
The most common side effects seen with either SC or IV Remodulin were
headache, diarrhea, nausea, rash, jaw pain, widening of the blood vessels
(vasodilatation), and swelling from fluid retention (edema). These are not
all the possible side effects of Remodulin. Call your doctor for medical
advice about side effects.
You may report side effects to the FDA at
www.fda.gov/MedWatch
or call 1-800-FDA-1088.
The risk information provided here is not comprehensive. To learn more about
Remodulin, talk with your healthcare provider. Please see
Full Prescribing Information
at
www.remodulin.com
or call Customer Service at
1-877-UNITHER
(1-877-864-8437).
REMISIconMAY2021
Important Safety Considerations for ADCIRCA®
(tadalafil)
-
You should discuss all of your medical conditions and all medications
with your healthcare provider before starting ADCIRCA
-
Do not take ADCIRCA if you take any medications that contain nitrates
(often used for chest pain) or guanylate cyclase stimulators, as the
combination could cause a sudden, unsafe drop in blood pressure
-
Do not take ADCIRCA if you are allergic to tadalafil or any other
ingredient in ADCIRCA
-
ADCIRCA is a type of medication called a phosphodiesterase 5 inhibitor
(PDE-5i) that can cause blood vessels to widen, which may result in a
decrease in blood pressure. If you have heart-disease or any problems
with low blood pressure, tell your healthcare provider before taking
ADCIRCA, as these conditions may be affected by the action of ADCIRCA
-
Talk with your healthcare provider if you are pregnant or planning to
become pregnant or if you are breastfeeding or plan to breast feed.
-
If you have ever had blockage in the veins of your lungs, known as
pulmonary veno-occlusive disease (PVOD), ADCIRCA is not recommended for
you
-
Taking ADCIRCA with alcohol, or blood pressure medications, such as
alpha-blockers, may lower blood pressure and cause hypotension
(light-headedness or fainting)
-
Do not take ADCIRCA if you are taking rifampin (an antibiotic for
certain bacterial infections), or antifungal medications, such as
ketoconazole and itraconazole. If you require treatment with both
ADCIRCA and ritonavir (Norvir®) at the same time, your
dose of ADCIRCA will need to be adjusted. Inform your healthcare
provider if you have kidney or liver problems before taking ADCIRCA
-
ADCIRCA contains the same ingredient (tadalafil) as
Cialis®, which is used to treat erectile dysfunction (ED,
impotence) and the signs and symptoms of benign prostatic hyperplasia
(BPH, enlarged prostate). If you are taking ADCIRCA, do not take Cialis
or other PDE-5is
-
In rare cases, patients reported side effects such as decreased eyesight
or loss of vision in one or both eyes (NAION), or sudden decrease or
loss of hearing, sometimes with ringing in the ears and dizziness. If
you experience any of these side effects after taking ADCIRCA, seek
medical attention right away
-
In rare cases, men taking PDE-5is (including tadalafil) for erectile
dysfunction reported side effects such as an erection lasting more than
four hours. If you experience a prolonged erection, seek medical
attention right away
-
The most common side effects of ADCIRCA are headache, muscle pain,
getting red or hot in the face (flushing), nausea, pain in the arms,
legs or back, upset stomach, stuffy or congested nose
ADC.ISI.CON.SEP2020
For more information about ADCIRCA, please see the
Full Prescribing Information
and
Patient Information
or call 1-800-545-5979.
Call your healthcare provider for medical advice about side effects. You
are encouraged to report negative side effects to the FDA at
www.fda.gov/medwatch
or call 1-800-FDA-1088.
What are TYVASO and TYVASO DPI?
TYVASO (treprostinil) Inhalation Solution and TYVASO DPI (treprostinil)
Inhalation Powder are prescription medicines used in adults to treat:
-
Pulmonary arterial hypertension (PAH; WHO Group 1), which is high blood
pressure in the arteries of your lungs. TYVASO or TYVASO DPI can improve the
ability to exercise. Your ability to exercise decreases 4 hours after taking
TYVASO or TYVASO DPI. It is not known if TYVASO or TYVASO DPI is safe and
effective in children under 18 years of age.
-
Pulmonary hypertension associated with interstitial lung disease (PH-ILD;
WHO Group 3), which is high blood pressure in the lungs due to inflammation
and sometimes scarring in the lungs. TYVASO or TYVASO DPI can improve the
ability to exercise.
IMPORTANT SAFETY INFORMATION FOR TYVASO and TYVASO DPI
Before you take TYVASO or TYVASO DPI, tell your healthcare provider about all
of your medical conditions, including if you:
- Have low blood pressure
- Have or have had bleeding problems
- Have asthma or chronic obstructive pulmonary disease (COPD)
-
Are pregnant or plan to become pregnant. It is not known if either product
will harm your unborn baby.
-
Are breastfeeding or plan to breastfeed. It is not known if either product
passes into your breast milk. Talk to your healthcare provider about the
best way to feed your baby during treatment.
Tell your healthcare provider about all of the medicines you take,
including prescription and over-the-counter medicines, vitamins, and herbal
supplements. Either product and other medicines may affect each other.
Especially tell your healthcare provider if you take:
- Medicines used to treat high blood pressure or heart disease
- Medicines that decrease blood clotting (anticoagulants)
- Water pills (diuretics)
-
Gemfibrozil (Lopid®) or rifampin (Rimactane®,
Rifadin®, Rifamate®, Rifater®)
What are the possible side effects of TYVASO or TYVASO DPI?
Both products can cause
serious side effects, including:
-
Low blood pressure (symptomatic hypotension). If
you have low blood pressure, either product may lower your blood pressure
more.
-
Bleeding problems. Either product may increase the
risk of bleeding, especially in people who take blood thinners
(anticoagulants).
The most common side effects of both products are
cough, headache, throat irritation and pain, nausea, reddening of the face and
neck (flushing), fainting or loss of consciousness, dizziness, diarrhea, and
shortness of breath. Like other inhaled prostaglandins, you may have trouble
breathing after taking TYVASO or TYVASO DPI because it may cause the muscles
around your airway to tighten (bronchospasm). These are not all the possible
side effects. Call your doctor for medical advice about side effects or if you
have trouble breathing.
You may report side effects to the FDA at
www.fda.gov/MedWatch
or call 1-800-FDA-1088.
The risk information provided here is not comprehensive. To learn more about
TYVASO or TYVASO DPI, talk with your healthcare provider. Please see Full
Prescribing Information for
TYVASO
or
TYVASO DPI, Instructions for Use manuals for
TD-100
and
TD-300
TYVASO® Inhalation System and
TYVASO DPI™ Inhalation Powder, and additional information at
www.TYVASO.com
or call 1-877-UNITHER
(1-877-864-8437).
TYVISIconMAY2022