Implantable System for Remodulin® (treprostinil)
Implantable System for Remodulin® (treprostinil) Injection
IMPORTANT SAFETY INFORMATION FOR ISR
WARNINGS AND CAUTIONS
Review the ISR patient manual, including information about Electromagnetic Interfernece (EMI), and the Remodulin drug labeling for detailed disclosure for complete information on what the Remodulin® Implantable System is, how it is implanted, and what you can expect after you have your implanted drug delivery system. As with any procedure, there are risks (potential events that can happen) involved in having an implanted drug delivery system. Some of the risks may require treatment with rest, medications, or procedures such as taking out fluid with a needle. Additional treatments, surgeries, removal or replacement of the drug pump or catheter, or a hospital stay may be needed. Some of the risks could result in loss of or change in your therapy, which may lead to a return of your Pulmonary Arterial Hypertension (PAH) symptoms. Talk to your doctor about signs and symptoms of getting too much, too little, or no Remodulin® (treprostinil) Injection. Failure to recognize these signs and symptoms and to get medical help can result in serious injury or death.
This drug delivery system continuously delivers Remodulin to your superior vena cava (the large vein above your heart). Your doctor programs your pump to deliver Remodulin at a specific dose. This drug delivery system should not be implanted if you had a recent infection that required you to take antibiotics; the pump cannot be implanted 1 inch or less from the surface of the skin; you do not have an appropriate body size to accept the pump bulk and weight or the length of the catheter; you have an existing external catheter or catheters that would remain in place after the pump implant. Talk to your doctor to determine if this drug delivery system is right for you.
Potential risks associated with the implant procedure: pain, swelling or bruising; low‑grade fever; nausea or vomiting; buildup of fluid around the pump; mishandling of the pump and the catheter during implant, resulting in an improperly functioning pump or catheter; collapsing of a lung; infection; punctures of the chest muscle, breast tissue, vein, and lung space; abnormal heart rhythm; short‑term overdose of Remodulin® (treprostinil) Injection or a sudden decrease in Remodulin, including symptoms and side effects associated with an underdose or an overdose; bleeding; blood clots; vein splitting or tearing; allergic reaction; stroke; death.
Risks associated with the drug delivery system: too much Remodulin being delivered, which may increase the side effects of Remodulin; a sudden stop or a large decrease in Remodulin, which may cause your PAH symptoms to return or get worse; the drug delivery system kinking, disconnecting, leaking, breaking, clogging, or moving, which may cause: severe pain, reaction to the drug, overdose or underdose of Remodulin; component failure, resulting in loss of therapy, drug overdose, or inability to program the pump; the implanted materials could cause an allergic or immune system response; infection; blocked or swollen veins; the pump could stop because the battery has run out or because of a problem with the pump’s inner parts; death.
Medical procedures: Always tell healthcare professionals that you have a drug delivery system for PAH before you have medical tests or procedures. Show them your patient ID card. Failure to tell healthcare professionals may delay your test or procedure and damage your implantable drug delivery system. Long-term catheter damage: The catheter is subject to wear. Over time, the catheter may fail and need surgical correction. Catheter failure can result in the drug leaking into surrounding tissue or an interruption of therapy.
Clinician programmer interaction with a cochlear implant: If you have a cochlear implant, keep the external part of the cochlear system as far away from the clinician programmer as you can. Turn the cochlear implant off during programming to prevent unintended audible clicks.
Electromagnetic interference (EMI): Everything that uses electricity produces an electromagnetic energy field. Most of the magnetic and electrical devices you are around in your daily life are not likely to affect your pump. However, sources of strong EMI may cause: injury from heating of the implanted pump and damage to surrounding tissue; system damage from electrical or mechanical effects, resulting in loss of or a change in therapy that can lead to serious injury; operational changes to the pump from strong magnets temporarily or permanently stopping the pump; electrical interference causing a pump memory error, resulting in loss of or change in therapy; change in flow rate from warming of the implanted pump, resulting in too much Remodulin being delivered. In rare instances, sources of EMI may stop the flow of Remodulin from your pump. The critical alarm on the pump will sound if this happens. Review the ISR patient manual for potential effects of EMI from other devices or medical procedures.
Specific activities can affect the implantable drug delivery system: for more information on the activities refer to the patient manual and discuss with your doctor before engaging in activities at altitudes greater than 2,438 meters (8,000 feet) (eg, hiking or skiing in the mountains); do not dive below 33 feet (10 meters) of water or enter hyperbaric chambers above 2.0 atmospheres absolute (ATA). Do not use a hot tub, a hot shower, a steam room, a sauna, or a tanning bed if the temperature is greater than 102°F (39°C). Avoid activities that can damage the system components or cause the catheter to come loose, such as sudden, excessive, or repetitive bending, twisting, bouncing, or stretching and do not manipulate or rub the pump or the catheter through the skin (also called Twiddler’s syndrome). Damage to the components of your drug delivery system can require surgery to repair or replace the components, or a loss of or change in therapy that can lead to serious injury. Notify your doctors or nurses of any travel plans to coordinate your care and pump refills to help prevent a loss of or change in therapy. If you have a pump and another active implanted device (for example, a pacemaker, a defibrillator, or a neurostimulator): the radio frequency signal used to program either device can reset or reprogram the other device; the magnet in a cardiac programmer may temporarily stop the pump.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. See the Patient Manual for detailed information. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.
Remodulin® (treprostinil) Injection
INDICATION OR 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 is safe 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 health care provider. Please see Full Prescribing Information at www.remodulin.com or call Customer Service at 1-877-UNITHER (1-877-864-8437).