INFORMATION: CONTENTS*
WARNING: THROMBOCYTOPENIA AND GLOMERULONEPHRITIS
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Information
2.2 Administration
2.3 Assessment Prior to Initiating TEGSEDI
2.4 Laboratory Testing and Monitoring to Assess Safety after Initiating TEGSEDI
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Thrombocytopenia
5.2 Glomerulonephritis and Renal Toxicity
5.3 TEGSEDI REMS Program
5.4 Stroke and Cervicocephalic Arterial Dissection
5.5 Inflammatory and Immune Effects
5.6 Liver Effects
5.7 Hypersensitivity Reactions/Antibody Formation
5.8 Uninterpretable Platelet Counts: Reaction between Antiplatelet Antibodies and ethylenediaminetetra-acetic acid (EDTA)
5.9 Reduced Serum Vitamin A Levels and Recommended Supplementation
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
7 DRUG INTERACTIONS
7.1 Antiplatelet Drugs or Anticoagulant Medications
7.2 Nephrotoxic Drugs
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
TEGSEDI is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Information
The recommended dose of TEGSEDI is 284 mg injected subcutaneously once weekly.
For consistency of dosing, patients should be instructed to give the injection on the same day every week.
If a dose is missed, patients should be instructed to take the missed dose as soon as possible, unless the next scheduled dose is within 2 days. In this situation, the patient should be directed to skip the missed dose and take the next scheduled dose on the scheduled day.
2.2 Administration
TEGSEDI is intended for subcutaneous use only.
The first injection administered by the patient or caregiver should be performed under the guidance of an appropriately qualified healthcare professional. Patients and/or caregivers should be trained in the subcutaneous administration of TEGSEDI in accordance with the Instructions for Use.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit [see How Supplied/Storage and Handling (16)].
Sites for injection include the abdomen, upper thigh region, or outer area of the upper arm. It is important to rotate sites for injection.
- If injected in the upper arm, the injection should be administered by a person other than the patient.
- Injection should be avoided at the waistline and other sites where pressure or rubbing from clothing may occur.
- TEGSEDI should not be injected into areas of skin disease or injury.
- Tattoos and scars should also be avoided.
TEGSEDI prefilled syringe should be allowed to reach room temperature prior to injection.
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