Inotersen injection

What is this medication?

Inotersen (in oh TER sen) is used to treat nerve damage in patients with a certain genetic disorder called hereditary transthyretin-mediated amyloidosis (hATTR).

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Tegsedi

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• kidney disease
• low blood counts, like low white cell, platelet, or red cell counts
• an unusual or allergic reaction to inotersen, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for injection under the skin. You will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 2 days, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medication?

This medicine may interact with the following medications:

• adenosine
• aspirin and aspirin-like medicines
• certain medicines that treat or prevent blood clots like warfarin, enoxaparin, dalteparin, apixaban, dabigatran, and rivaroxaban
• cisplatin
• clopidogrel
• cyclosporine
• diuretics
• medicines for infection like acyclovir, adefovir, amphotericin B, bacitracin, cidofovir, foscarnet, ganciclovir, gentamicin, pentamidine, vancomycin
• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
• pamidronate
• prasugrel
• ticagrelor
• ticlopidine
• zoledronic acid

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your healthcare professional if your symptoms do not start to get better or if they get worse.

You should make sure you get enough vitamin A while you are taking this medicine. Discuss the foods you eat and the vitamins you take with your healthcare professional.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat; palpitations; feeling faint or lightheaded, falls; breathing problems
• signs and symptoms of a stroke like changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination
• signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eyes, gums, or nose
• signs and symptoms of infection like fever or chills; cough; sore throat; pain or trouble passing urine
• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• headache
• joint pain
• loss of appetite
• muscle pain
• nausea, vomiting
• pain, redness, or irritation at site where injected
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

You will be instructed on how to store this medicine. Throw away any unused medicine after the expiration date on the label.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.