Inotersen Prefilled Syringe (INOTERSEN - SUBCUTANEOUS INJECTION)

Inotersen Prefilled Syringe (INOTERSEN - SUBCUTANEOUS INJECTION)

For amyloidosis.

Brand Name(s): Tegsedi

Generic Name: Inotersen

Instructions

This medicine is injected into the skin. Ask your doctor, nurse, or pharmacist where on your body this medicine can be injected and how to inject it.

Read and make sure you understand the instructions for measuring dose and using syringe. If you have any questions, talk to your doctor, nurse, or pharmacist.

The liquid should be clear or light yellow.

Do not use the medicine if it contains any particles or if it has changed color.

Do not shake the medicine before using.

Keep medicine in refrigerator. Do not freeze. Protect from light.

Keep the medicine in its original container.

You may store this medicine at room temperature for up to 6 weeks.

If your medicine is stored in the refrigerator, take it out of the refrigerator about 30 minutes before use to warm to room temperature.

Please ask your doctor, nurse, or pharmacist how to discard unused medicines safely.

Ask your doctor, nurse or pharmacist to show you how to use this medicine correctly.

Do not inject into skin that is bruised, tender, red, hard or has scars or stretch marks.

Change location of injection each time.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to use a dose on time, use it as soon as you remember. If it is within 2 days of the next dose, do not use the missed dose. Return to your normal dosing schedule. Do not take 2 doses of this medicine at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

During pregnancy, this medicine should be used only when clearly needed. Talk to your doctor about the risks and benefits.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

There is an increased risk of bleeding while on this medicine, please tell your doctor or nurse if you notice any excessive bleeding or bruising.

It is unknown if this medicine passes into breast milk. Ask your doctor before breastfeeding.

Ask your pharmacist how to properly throw away used needles or syringes.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • decreased appetite
  • lack of energy and tiredness
  • fever
  • headaches
  • pain, redness, swelling near injection
  • nausea and vomiting
  • numbness or tingling of the skin

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • back pain
  • bleeding or bruising
  • blurry vision
  • chest pain
  • coughing up blood or vomit that looks like coffee grounds
  • swelling of the legs, feet, and hands
  • nosebleeds
  • dry eyes
  • feeling of heat or flushing
  • bleeding gums
  • severe or persistent headache
  • signs of kidney damage (such as change in urine color or bubbly urine)
  • signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
  • joint or muscle pain
  • neck pain or stiffness
  • small red, purple or brown spots on the skin
  • shortness of breath
  • blood in stool
  • symptoms of stroke (such as one-sided weakness, slurred speech, confusion)
  • difficulty swallowing
  • blood in urine
  • excessive vaginal bleeding
  • vision problems - difficulty seeing at night

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.