Patisiran parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Infusions of patisiran.
Drugs List
Therapeutic Indications
Uses
Polyneuropathy in patients with hereditary transthyretin amyloidosis
Treatment of hereditary transthyretin mediated amyloidosis in adult patients with stage one or two polyneuropathy.
Dosage
Adults
300micrograms/kg once every three weeks.
Maximum dose of 30mg for patients weighing more than or equal to 100kg.
Additional Dosage Information
Premedication
To reduce the risk of infusion related reactions (IRR), the following medicinal products should be given at least 60 minutes before infusion of patisiran:
Intravenous corticosteroid (dexamethasone 10mg, or equivalent)
Oral paracetamol 500mg
Intravenous H1 blocker (diphenhydramine 50mg, or equivalent)
Intravenous H2 blocker (ranitidine 50mg, or equivalent)
The corticosteroid may be tapered in decrements no greater than 2.5mg to a minimum of 5mg dexamethasone. Before each reduction in corticosteroid premedication, the patient should receive 3 consecutive IV infusions of patisiran without experiencing IRRs.
If necessary additional or higher doses of one or more of the premedications may be administered to reduce the risk of IRRs.
Vitamin A supplementation
2500 units once a day.
Missed doses
A missed dose of patisiran should be administered as soon as possible.
If administered within 3 days of a missed dose, the dosing schedule should be continued according to the original schedule.
If administered more than 3 days after the missed dose, dosing should be continued every 3 weeks thereafter.
Administration
For intravenous use only.
Patisiran should be diluted prior to use.
Contraindications
Children under 18 years
Breastfeeding
Pregnancy
Precautions and Warnings
Restricted sodium intake
End stage renal disease
Liver transplant
Moderate hepatic impairment
Severe renal impairment
Sodium content of formulation may be significant
Consider premedication with antihistamine and/or corticosteroid
Correct vitamin A deficiency before starting treatment
Treatment to be initiated and supervised by a specialist
Vitamin A supplement is advised during treatment
Must be diluted before use
Exclude pregnancy prior to initiation of treatment
Discontinue treatment immediately if pregnancy is suspected
Interrupt therapy/reduce infusion rate if infusion-related reactions occur
May affect results of some laboratory tests
Discontinue permanently if life threatening infusion reactions occur
Female: Ensure adequate contraception during treatment
Treatment may lead to a decrease in vitamin A levels, ocular symptoms of vitamin A deficiency should be evaluated and corrected before treatment is initiated.
Abnormal vitamin A levels is associated with an increased risk of foetal malformation. Treatment should be discontinued if the women intends to become pregnant and vitamin A levels should be returned to normal before conception is attempted. Supplementation of vitamin A should be discontinued unless the women is vitamin A deficient.
Pregnancy and Lactation
Pregnancy
Patisiran is contraindicated during pregnancy.
The manufacturer advises not using patisiran during pregnancy unless the clinical condition of the women requires treatment. Animal studies are insufficient regarding reproductive toxicity. At the time of writing there is limited published information regarding the use of patisiran during pregnancy. The potential risks are unknown. In the event of an unplanned pregnancy, vitamin A and thyroid stimulating hormone (TSH) levels should be taken early in the pregnancy, and the foetus should be monitored carefully particularly during the first trimester.
Lactation
Patisiran is contraindicated during breastfeeding.
The manufacturer advises that the patient either discontinues patisiran or discontinues breastfeeding. It is unknown if patisiran is excreted in human milk. Animal studies have shown small amounts of patisiran are excreted in milk. The effects on exposed infants are unknown.
Side Effects
Abdominal pain
Arthralgia
Bronchitis
Burning sensation
Cellulitis
Chest discomfort
Chest pain
Chills
Cough
Dermatitis
Dizziness
Dyspepsia
Dyspnoea
Erythema
Extravasation
Facial oedema
Fatigue
Flushing
Headache
Hypertension
Hypotension
Increased heart rate
Infusion related reaction
Local pain (injection site)
Muscle spasm
Musculoskeletal pain
Nausea
Palpitations
Peripheral oedema
Phlebitis
Pruritus
Rash
Rhinitis
Sinusitis
Swelling (injection site)
Syncope
Thrombophlebitis
Vertigo
Effects on Laboratory Tests
Laboratory tests for serum vitamin A should not be used to guide vitamin A supplementation during treatment. Readings may not reflect the total amount of vitamin A in the body.
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: September 2020
Reference Sources
Summary of Product Characteristics: Onpattro 2mg/ml concentrate for solution for infusion. Alnylam UK Ltd. Revised November 2020.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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