Please wait while the formulary information is being retrieved.
TEGSEDI (inotersen sodium)
- Transthyretin familial amyloid polyneuropathy
284 mg/1.5 mL subcutaneous syringe
- Inject 1.5 milliliters (284 mg) by subcutaneous route once weekly in the abdomen, thigh, or outer area of upper arm (rotate sites)
Transthyretin familial amyloid polyneuropathy
- Inject 1.5 milliliters (284 mg) by subcutaneous route once weekly (same day), in the abdomen, thighs, or outer area of upper arm (rotate sites)
- Inject 1.5 milliliters (284 mg) by subcutaneous route once weekly in the abdomen, thigh, or outer area of upper arm (rotate sites)
- None
Contraindicated
- None
Severe
Moderate
- None
- Liver transplant rejection
Contraindicated
- Abnormal hepatic function tests
- Glomerulonephritis
- Thrombocytopenic disorder
Severe
Moderate
- None
TEGSEDI (inotersen sodium)
- Transthyretin familial amyloid polyneuropathy
- Hyperbilirubinemia
- Thrombocytopenic disorder
- Fatigue
- Fever
- Headache disorder
- Injection site sequelae
- Nausea
- Vitamin A deficiency
More Frequent
Severe
Less Severe
- Abnormal hepatic function tests
- Anemia
- Bacterial infection
- Cardiac arrhythmia
- Cervicocephalic arterial dissection
- Chorea
- Eosinophilia
- Glomerulonephritis
- Hypersensitivity drug reaction
- Hypertension
- Increased alanine transaminase
- Increased aspartate transaminase
- Kidney disease with reduction in GFR
- Nephrotic syndrome
- Orthostatic hypotension
- Anorexia
- Arthralgias
- Bruising
- Cachexia
- Chest pain
- Chills
- Dysphagia
- Dyspnea
- Flu-like symptoms
- Flushing
- Myalgias
- Palmar rash
- Paresthesia
- Peripheral edema
- Syncope
- Vomiting
- Xerostomia
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- ANCa-positive vasculitis
- Cerebrovascular accident
- Clostridium difficile infection
- Paraplegia
Less Severe
- Gait abnormality
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Inotersen
No pediatric safety and efficacy established.
- 1 Day – 18 Years
- No pediatric safety and efficacy established.
Inotersen
- Severity Level:
2
- Additional Notes: Insufficient human data available.
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Inotersen
Insufficient data available
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Insufficient data available |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
Inotersen
General-Patients 65 years and older may be at increased risk of certain adverse reactions, such as congestive heart failure, chills, myalgia, and extremity pain.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | N | N | Y | N | N | N |
BEERS: N HEDIS: N STOPP: N
No Known Risk
None
- This medication decreases the number of platelets in your blood, which may cause serious (even fatal) bleeding problems. Tell your doctor right away if you notice symptoms such as easy bruising, a rash of tiny reddish-purple spots (especially on your lower legs), bleeding gums, nosebleeds, blood in urine/stools, vomiting or coughing up blood, neck stiffness, unusual severe headache, or unusual/heavy menstrual periods (women). This medication can cause serious kidney damage that may result in the need for dialysis.<br /><br />Tell your doctor right away if you have swelling in your face/feet/hands, shortness of breath, cough, blood in urine, brown/foamy urine, or change in amount of urine. Careful monitoring and treatment by your doctor may decrease your risk for serious side effects. Lab and/or medical tests (such as kidney/liver function, complete blood count, urine tests) should be done before you start using this medication, while you are using it, and for 8 weeks after stopping treatment.<br /><br /> Keep all medical and lab appointments. For patients to receive this medication, all doctors, pharmacists, and patients must agree to, understand, and carefully follow the requirements of the Tegsedi REMS Program. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.
| Transthyretin familial amyloid polyneuropathy | |
| E85.1 | Neuropathic heredofamilial amyloidosis |
| E85.82 | Wild-type transthyretin-related (ATTr) amyloidosis |
| G63 | Polyneuropathy in diseases classified elsewhere |
| 0-9 | A-Z |
|---|---|
| E85.1 | Neuropathic heredofamilial amyloidosis |
| E85.82 | Wild-type transthyretin-related (ATTr) amyloidosis |
| G63 | Polyneuropathy in diseases classified elsewhere |
Formulary Reference Tool