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GIVLAARI is a brand name for Givosiran, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: GIVLAARI (givosiran) is indicated for the treatment of acute hepatic porphyria (AHP) in adults. 1.1 Pediatrics Pediatrics (<18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of GIVLAARI in pediatric patients has not been established; therefore, Health Canada has not…
Verbatim from this product's HC label. Tap a section to expand.
and 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions). 2 Geriatrics Geriatrics (≥65 years of age): Clinical studies of GIVLAARI did not include sufficient numbers of patients to determine if the use in geriatric patients is associated with differences in safety or effectiveness (see 7 WARNINGS AND PRECAUTIONS, Special Populations, 4 DOSAGE AND ADMINISTRATION and 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions).
, anaphylaxis) to givosiran or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see
, Clinical Trial Adverse Reactions). 2%) patient treated with placebo had an increased alanine aminotransferase (ALT) greater than 3 times the ULN. Transaminase elevations primarily occurred between 3 to 5 months following initiation of treatment.
In 5 patients treated with GIVLAARI, the transaminase elevations resolved with ongoing dosing. 25 mg/kg. ALT elevations resolved in both patients. Measure liver function tests prior to initiating treatment with GIVLAARI, repeat every month during the first 6 months of treatment, and as clinically indicated thereafter.
Consider interrupting or discontinuing treatment for severe or clinically significant transaminase elevations. For resumption of dosing after interruption see 4 DOSAGE AND ADMINISTRATION, Recommended Dose and Dosage Adjustment. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Subcutaneous injection 189 mg givosiran per mL Water for injection, Phosphoric acid and/or Sodium hydroxide (for pH adjustment) GIVLAARI (givosiran) Page 8 of 29 Immune Anaphylactic reaction In clinical trials, anaphylaxis occurred in one patient with a history of allergic asthma and atopy (see 8 ADVERSE REACTIONS, Less Common Clinical Trial Adverse Reactions).
Monitor for signs and symptoms of anaphylaxis. If anaphylaxis occurs, immediately discontinue administration of GIVLAARI and institute appropriate medical treatment. Renal Increases in serum creatinine levels and decreases in estimated glomerular filtration rate (eGFR) have been reported during treatment with GIVLAARI (see 8 ADVERSE REACTIONS, Clinical Trial Adverse Reactions).
5 mg/kg GIVLAARI. 73 m2) showed severe hyperhomocysteinemia upon givosiran treatment (see 7 WARNINGS AND PRECAUTIONS, Hyperhomocysteinemia). Monitor renal function during treatment with GIVLAARI as clinically indicated. Progression of renal impairment has been observed in some patients with pre-existing renal disease.
, Special Populations, 4 DOSAGE AND ADMINISTRATION and 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions). 2 Geriatrics Geriatrics (≥65 years of age): Clinical studies of GIVLAARI did not include sufficient numbers of patients to determine if the use in geriatric patients is associated with differences in safety or effectiveness (see 7 WARNINGS AND PRECAUTIONS, Special Populations, 4 DOSAGE AND ADMINISTRATION and 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions).
, anaphylaxis) to givosiran or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 1 Dosing Considerations • GIVLAARI (givosiran) should be administered by a healthcare professional.
• It is supplied in a single use vial, as a ready to use solution that does not require additional reconstitution or dilution prior to administration. • Measurement of blood homocysteine and vitamin levels prior to initiating treatment and monitoring for changes in blood homocysteine during treatment with GIVLAARI is recommended (see 7 WARNINGS AND PRECAUTIONS, Hyperhomocysteinemia).
5 mg/kg once monthly. • For administration by subcutaneous injection only. Dosing is based on body weight. 5 mg/kg once monthly, as clinically indicated (see 7 WARNINGS AND PRECAUTIONS, Hepatic). 5 mg/kg once monthly. There are limited data on efficacy and safety of the lower dose, particularly in patients who previously experienced transaminase elevations.
5 mg/kg dose after dose interruption due to elevations in transaminases. For patients whose hyperhomocysteinemia persist or worsen while on supplemental vitamin therapy (see 7 WARNINGS AND PRECAUTIONS, Hyperhomocysteinemia), alternative adjunctive treatment options or suspension of treatment should be considered.
5×ULN) (see 7 WARNINGS AND PRECAUTIONS, Hepatic and 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions). GIVLAARI has not been studied in patients with moderate or severe hepatic impairment. 73 m2). 73 m2) and therefore caution is recommended with the use of GIVLAARI in these patients.
, anaphylaxis) to givosiran or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Careful monitoring of renal function during treatment is required in such cases. Caution is recommended in patients with severe renal impairment. 73 m2), or in patients on dialysis (see 4 DOSAGE AND ADMINISTRATION). Hyperhomocysteinemia Hyperhomocysteinemia (greater than 15 micromol/L of homocysteine in the blood) may be observed in patients with AHP, vitamin deficiencies (vitamin B6, folic acid, vitamin B12), chronic kidney disease, mutation in the MTHFRC677T gene or an increase in plasma methionine levels.
Worsening of Hyperhomocysteinemia [from moderate (15-30 micromol/L) to intermediate (30- 100 micromol/L) or severe (>100 micromol/L)] has been observed upon treatment with GIVLAARI (see 8 ADVERSE REACTIONS, Clinical Trial Adverse Reactions).
Measurement of blood homocysteine levels prior to initiating treatment and monitoring for changes during treatment with GIVLAARI is recommended. In patients with elevated homocysteine levels, consider treatment with a supplement containing vitamin B6 as monotherapy or a multivitamin preparation.
Reproductive Health:
Female and Male Potential • Fertility There are no data on the effects of GIVLAARI on human fertility. No impact on male or female fertility was detected in animal studies (see 16 NON-CLINICAL TOXICOLOGY). 1 Pregnant Women There is insufficient data with GIVLAARI use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
The clinical need for GIVLAARI during pregnancy should be considered along with expected health benefits to the mother and any potential adverse effects on the fetus from GIVLAARI or from the underlying maternal condition. Studies in animals have shown reproductive toxicity in the presence of maternal toxicity (see 16 NON- CLINICAL TOXICOLOGY).
2 Breast-feeding There are no data on the presence of GIVLAARI in human milk, the effects on the breastfed child, or the effects on milk production. A risk to the newborns/infants cannot be excluded and precaution should be exercised because many drugs can be excreted in human milk.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for GIVLAARI and any potential adverse effects on the breastfed infant from GIVLAARI or from the underlying maternal condition.
Available pharmacodynamic/toxicological data in animals have shown excretion of givosiran in milk. 3 Pediatrics Pediatrics (<18 years of age): The safety and efficacy of GIVLAARI have not been studied in pediatric patients (see 4 DOSAGE AND ADMINISTRATION, 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions).
No clinical data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use in patients <18 years of age. 4 Geriatrics Geriatrics (≥ 65 years of age): Clinical studies of GIVLAARI did not include sufficient numbers of patients to determine if the use in geriatric patients is associated with differences in safety or effectiveness (see 4 DOSAGE AND ADMINISTRATION, 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions).
1 Adverse Reaction Overview In placebo-controlled and open-label clinical studies, a total of 111 patients with AHP received GIVLAARI for up to 35 […]
73 m2), or in patients on dialysis (see 7 WARNINGS AND PRECAUTIONS, Renal and 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions).
Pediatrics (<18 years of age):
Based on the data submitted and reviewed by Health Canada, the safety and efficacy of GIVLAARI in pediatric patients has not been established; Health Canada has not authorized an indication for pediatric use (see 7 WARNINGS AND PRECAUTIONS, Special Populations, and 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions).
Geriatrics (≥65 years of age):
Clinical studies of GIVLAARI did not include sufficient numbers of patients to determine if the use in geriatric patients is associated with differences in safety or effectiveness (see 7 WARNINGS AND PRECAUTIONS, Special Populations, and 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions).
4 Administration For subcutaneous administration by healthcare professionals only. Ensure that medical support is available to manage anaphylactic reactions appropriately when administering GIVLAARI (see 7 WARNINGS AND PRECAUTIONS).
Use aseptic technique. This medicinal product is provided as a ready-to-use solution in a single-use vial (189 mg/mL). Once the vial is opened, use immediately. GIVLAARI (givosiran) Page 6 of 29 • Calculate the required volume of GIVLAARI based on the recommended weight based dosage (see 4 DOSAGE AND ADMINISTRATION, Recommended Dose and Dosage Adjustment).
• The solution should be inspected visually for clarity, particulate matter, precipitation, discoloration, and leakage prior to administration. Do not use product if solution shows haziness, particulate matter, discoloration, or leakage.
• Withdraw the indicated injection volume of GIVLAARI using a 21 gauge or larger needle. 5 mL equally into multiple syringes. • Replace the 21 gauge or larger needle with either a 25 gauge or 27 gauge needle with 1/2-inch or 5/8-inch needle length.
• Avoid having GIVLAARI on the needle tip until the needle is in the subcutaneous space. • Administer injection into the abdomen, the back or side of the upper arms, or the thighs. Rotate injection sites. o If injecting into the abdomen, avoid a 5 cm diameter circle around the navel.
o If more than one injection is needed for a single dose of GIVLAARI, the injection sites should be at least 2 cm apart from previous injection locations. o An injection should never be given into scar tissue or areas that are erythematous, inflamed, or […]