Loading…
ONAKTA is a brand name for Tirbanibulin, supplied as a ointment. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ONAKTA (tirbanibulin 1 % w/w ointment) is indicated for: • the topical treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (AK) (Olsen grade 1) on the face or scalp in adults. 1.1 Pediatrics Pediatrics (< 18 years): No data are available to Health Canada; therefore, Health Canada has not authorized an…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations The efficacy of ONAKTA (tirbanibulin 1 % w/w ointment) for more than 1 treatment course of 5 consecutive days have not been studied. If recurrences occur, or new lesions develop within the treatment area, other therapeutic options may be considered.
2 Recommended Dose and Dosage Adjustment • ONAKTA should be applied to the affected field on the face or scalp once daily for 5 consecutive days using 1 single-dose sachet per application. • Sufficient amount of ONAKTA ointment should be applied to form a thin layer to cover the treatment field of up to 25 cm2.
• Each sachet is for single use only and should be discarded after use. • ONAKTA has not been studied in patients with renal or hepatic impairment. Based on clinical pharmacology and in vitro studies, no dose adjustments are needed. • Health Canada has not authorized an indication for pediatric use.
4 Administration Before applying ONAKTA, patients should wash the treatment field with mild soap and water and dry it. Hands should be washed with soap and water before and immediately after application of the ointment. The ointment should be applied at approximately the same time each day.
The treated area should not be bandaged or otherwise occluded (see 7 WARNINGS AND PRECAUTIONS, 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS). Washing and touching of the treated area should be avoided for approximately 8 hours after application of ONAKTA.
After this period, the treated area may be washed with mild soap and water. 5 Missed Dose If a dose is missed, the patient should apply the ointment as soon as he/she remembers and then he/she should continue with the subsequent schedule.
However, the ointment should not be applied more than once a day.
and 14 CLINICAL TRIALS). Washing and touching of the treated area should be avoided for approximately 8 hours after application of ONAKTA. After this period, the treated area may be washed with mild soap and water. 5 Missed Dose If a dose is missed, the patient should apply the ointment as soon as he/she remembers and then he/she should continue with the subsequent schedule.
However, the ointment should not be applied more than once a day. 5 OVERDOSAGE Overdose of ONAKTA (tirbanibulin 1 % w/w ointment) could cause an increase in incidence and severity of local skin reactions. No systemic signs of overdose are expected following topical application of ONAKTA due to the low systemic absorption of tirbanibulin.
Management of overdose should consist of treatment of clinical symptoms. For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 Dosage Forms, Strengths, Composition and Packaging ONAKTA (tirbanibulin 1 % w/w ointment) is a white to off-white ointment and is supplied in single-dose sachets containing 250 mg of ointment.
5 mg (1% w/w) of tirbanibulin. Each sachet should be discarded after single use. Available in box of 5 single-dose sachets. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Topical 1 % w/w Each gram of ONAKTA contains 10 mg of tirbanibulin (10 mg/g).
Glycerol monostearate 40-55 Type I and propylene glycol ONAKTA (Tirbanibulin Ointment) Page 6 of 21 7 WARNINGS AND PRECAUTIONS General The safety and efficacy of ONAKTA (tirbanibulin 1 % w/w ointment) treatment have not been evaluated in clinical trials on body areas apart from the face and scalp.
ONAKTA must not be ingested. If accidental ingestion occurs, the patient should drink plenty of water and seek immediate medical care. ONAKTA is for external topical use on the face or scalp only; not for oral or ophthalmic use. Application near and around the eyes, lips, mouth and the inside of nostrils or ears should be avoided.
• ONAKTA (tirbanibulin 1 % w/w ointment) is contraindicated in patients who are hypersensitive to this drug 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.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Carcinogenesis and Mutagenesis Tirbanibulin induced chromosomal damage and micronuclei in genotoxicity studies conducted in rats. Tirbanibulin was shown to be non-mutagenic in bacterial mutagenesis test (16 NON-CLINICAL TOXICOLOGY, Carcinogenicity, Genotoxicity).
Driving and Operating Machinery ONAKTA has minimal influence on the ability to drive and use machines. Immune The safety and efficacy of ONAKTA treatment have not been evaluated in immunocompromised patients therefore, ONAKTA should be used with caution in immunocompromised patients.
Ophthalmologic ONAKTA may cause eye irritation. Avoid transfer of the drug into the eyes and to the periocular area during and after application. Wash hands immediately after application. In the event of accidental contact with the eyes, the eyes should be rinsed immediately with large amounts of water, and the patient should seek medical care as soon as possible.
Reproductive Health:
Female and Male Potential • Fertility No human data on the effect of ONAKTA on fertility are available. Tirbanibulin has been assessed for effects on fertility or reproductive function in rats. In a non-clinical fertility and early embryonic development study, oral administration of 4 mg/kg/day of tirbanibulin to male rats caused fertility toxicity (16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
• Teratogenic Risk No human data on the teratogenic effect of ONAKTA are available. 1 Pregnant Women, 16 NON- CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology). Skin Application of ONAKTA is not recommended until the skin is healed from any previous medicinal product, procedure or surgical treatment and should not be applied to open wounds or broken skin where the skin barrier is compromised.
ONAKTA (Tirbanibulin Ointment) Page 7 of 21 Occlusion after topical application of ONAKTA is more likely to result in irritation (see 8 ADVERSE REACTIONS, Dermal Safety Studies). Propylene glycol may cause skin irritation. Local skin reactions in the treated area, including erythema, flaking/scaling, crusting, swelling, erosion/ulceration, and vesiculation/pustulation, may occur after topical application of ONAKTA (see 8 ADVERSE REACTIONS).
Treatment effect may not be adequately assessed until resolution of local skin reactions. • Sun exposure Due to the nature of the disease, excessive exposure to sunlight (including sunlamps and tanning beds) should be avoided or minimised.
• Risk of progression to skin cancer Changes in the appearance of actinic keratosis could suggest progression to invasive squamous cell carcinoma. Clinically atypical lesions or lesions suspicious for malignancy should be appropriately managed (see 8 ADVERSE REACTIONS).
1 Pregnant Women ONAKTA is not recommended during pregnancy and in women of childbearing potential not using contraception. There are no clinical data regarding the use of ONAKTA in pregnant women or the impact on fertility, major birth defects, miscarriage or adverse maternal and fetal outcomes.
Tirbanibulin has been shown to have teratogenic properties. In non-clinical studies, oral administration of tirbanibulin in rats and rabbits is associated with maternal toxicity and embryo-fetal toxicity including implantation loss and teratogenicity (16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
2 Breast-feeding It is unknown if ONAKTA or its metabolites are excreted in human milk. Precaution should be exercised because many drugs can be excreted in human milk, therefore a risk to the newborns/infants cannot be excluded. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ONAKTA and any […]