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LEO PHARMA - TACROLIMUS is a brand name for Tacrolimus, supplied as a ointment. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: FOR DERMATOLOGIC USE ONLY, NOT FOR OPHTHALMIC USE. Acute Treatment LEO Pharma – Tacrolimus, both 0.03% and 0.1% for adults and only 0.03% for children aged 2 to 15 years is indicated as a second-line therapy for short and long-term intermittent treatment of moderate to severe atopic dermatitis in non-immunocompromised…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Cutaneous bacterial or viral infections should be resolved before commencing LEO Pharma - Tacrolimus ointment treatment. PrLEO Pharma - Tacrolimus Page 5 of 33 Minimise or avoid natural or artificial sunlight exposure during LEO Pharma - Tacrolimus ointment treatment.
Limit application of LEO Pharma - Tacrolimus ointment only to areas affected by atopic dermatitis and avoid long-term continuous use of topical calcineurin inhibitors, including LEO Pharma - Tacrolimus ointment (see Administration).
The safety of LEO Pharma - Tacrolimus ointment has not been established beyond one year of non-continuous use. Please refer to WARNINGS AND PRECAUTIONS section. 1%. 03% only. 3 Administration LEO Pharma - Tacrolimus can be used for short-term and intermittent long-term treatment.
Each affected region of the skin should be treated with LEO Pharma - Tacrolimus until lesions are cleared, almost cleared or mildly affected. Thereafter, patients who have a high frequency of flares (≥ 5 times per year) are considered suitable for maintenance treatment.
At the first signs of recurrence (flares) of the disease symptoms, twice daily treatment should be re -initiated. The use of LEO Pharma - Tacrolimus under occlusion has not been studied; therefore occlusive dressings are not recommended.
1% should be applied topically morning and evening twice daily as a thin layer to affected areas of skin, including the face, neck and eyelids. If no improvement occurs after 6 weeks of therapy or in case of disease exacerbation, LEO Pharma - Tacrolimus therapy should be discontinued, and patients should consult their physicians.
Maintenance Therapy Patients who have a high frequency of flares (≥ 5 times per year) and are responding to up to 6 weeks of acute treatment with tacrolimus ointment twice daily are suitable for maintenance therapy. 1% should be applied once daily twice a week.
, Monday and Thursday). LEO Pharma – Tacrolimus should be applied as a thin layer to the areas of the skin normally affected by atopic dermatitis (including the face, neck and eyelids). If signs of flares reoccur, twice daily treatment should be reinitiated (see Acute Treatment).
After 12 months, a review of the patient`s condition should be conducted by the physician and a decision taken whether to continue maintenance therapy in the absence of safety data for maintenance therapy beyond 12 months. In children, this review should include suspension of treatment to assess the need to continue this regimen and to evaluate the course of the disease.
1 Adverse Reaction Overview In normal volunteer dermal safety studies, LEO Pharma - Tacrolimus was neither phototoxic, nor photoallergenic, nor a contact sensitizer. Overall, 14,828 patients treated with LEO Pharma - Tacrolimus were evaluated in phase 3 studies and the cumulative topical exposure from the market experience is estimated to be 24 million patient years.
Spontaneous cases of T cell lymphomas, other types of lymphoma, and skin cancers have been reported in patients using tacrolimus ointment. However, overall experience from clinical trials, data from large post-authorization safety studies and post-marketing surveillance has failed to establish a causal relationship between topical use of tacrolimus and malignancies.
2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Treatment Clinical Trials with Tacrolimus Ointment Compared to Active Comparators In three active comparator studies using topical corticosteroids with tacrolimus ointment, the duration of treatment was 3 weeks.
In the adult study, the most common adverse events experienced were skin burning and pruritus, which were primarily application -site events caused by the medication. 1% tacrolimus ointment group experienced an application-site adverse event.
Both skin burning and pruritus tended to be brief; the occurrence of which decreased with time, lasting approximately 4-7 days. Other adverse events reported in this clinical trial included flu -like symptoms, folliculitis, headache, allergic reaction, skin erythema, maculopapular rash, nausea, diarrhea and paresthesia.
General Prolonged systemic exposure to calcineurin inhibitors has been associated with an increased risk of infections, lymphomas and skin malignancies. These risks are associated with the intensity and duration of immunosuppression.
Therefore, LEO Pharma - Tacrolimus should not be used in immunocompromised adults and children. While a causal relationship has not been established, cases of skin malignancy and lymphoma have been reported in patients treated with topical calcineurin inhibitors, including LEO Pharma – Tacrolimus.
The use of LEO Pharma – Tacrolimus should be avoided on pre-malignant and malignant skin conditions. Some malignant skin conditions, such as cutaneous T-cell lymphoma (CTCL), may mimic atopic dermatitis. If signs and symptoms of atopic dermatitis do not improve within 6 weeks of twice daily treatment, LEO Pharma – Tacrolimus treatment should be discontinued, and patients should be re-examined by their healthcare provider and their diagnosis be confirmed.
Patients should minimize or avoid natural or artificial sunlight exposure during the course of treatment, even while LEO Pharma – Tacrolimus is not on the skin. It is not known whether LEO Pharma - Tacrolimus interferes with skin response to ultraviolet damage.
The safety of LEO Pharma-Tacrolimus ointment has not been established beyond one year of non-continuous use. 1% (w/w) White petrolatum, mineral oil, propylene carbonate, white wax and paraffin PrLEO Pharma - Tacrolimus Page 7 of 33 viral infections at treatment sites should be resolved.
Carcinogenesis and Mutagenesis Prolonged use of calcineurin inhibitors for sustained immunosuppression in animal studies and systemic administration in transplant patients has been associated with an increased risk of lymphomas and skin malignancies.
Although a causal relationship has not been established, cases of skin malignancy and lymphoma have been reported in patients treated with topical calcineurin inhibitors, including LEO Pharma - Tacrolimus, during post-marketing surveillance (see Post-Market Adverse Drug Reactions, Clinical Trials and PART II, Toxicology).
LEO Pharma – Tacrolimus is contraindicated in patients with a history of hypersensitivity to tacrolimus or to any other component of the preparation. For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tacrolimus in Canada.
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4 Missed Dose If you forget to use LEO Pharma - Tacrolimus as directed, apply it as soon as possible, then go PrLEO Pharma - Tacrolimus Page 6 of 33 back to your regular schedule.
None of these adverse events showed a significant difference in incidence among the treatment groups. 1% hydrocortisone butyrate group. As in the adult study, skin burning and pruritus comprised the most common application site adverse events and tended to occur only during the first few days of treatment in this pediatric PrLEO Pharma - Tacrolimus Page 10 of 33 comparator study.
1% tacrolimus ointment group experienced an application site adverse event. There was a marked decrease in the prevalence of skin burning over time, particularly in the tacrolimus ointment treatment groups. Pruritus also decreased over time in the tacrolimus ointment treatment groups but not in the hydrocortisone acetate group.
The incidence of other adverse events that may be associated with treatment was similar among all study groups and included flu-like symptoms, fever, abdominal pain, increased cough, rhinitis, diarrhea and headache. Clinical Trials with Tacrolimus Ointment Compared to Vehicle Ointment Table 1 describes the adjusted incidence of adverse events (≥3%) pooled across the 3 identically designed 12-week, vehicle-controlled Phase 3 studies (two adult studies, one pediatric study).
03% (N=210) % Lymphadenopathy 2 2 1 0 3 Nausea 4 3 2 0 1 Skin tingling* 2 3 8 1 2 Dyspepsia* 1 1 4 0 0 Dry skin 7 3 3 0 1 Hyperesthesia* 1 3 7 0 0 Peripheral edema 2 4 3 0 0 Varicella zoster/Herpes zoster*,** 0 1 0 0 5 Contact dermatitis 1 3 3 3 4 Asthenia 1 2 3 0 0 Insomnia 3 4 3 1 1 Exfoliative dermatitis 3 3 1 0 0 Dysmenorrhea 2 4 4 0 0 Myalgia* 0 3 2 0 0 Cyst* 0 1 3 0 0 Arthralgia 1 1 3 2 0 Paresthesia 1 3 3 0 0 * May be reasonably associated with the use of tacrolimus ointment ** All the herpes zoster cases in the pediatric 12-week study were reported as chicken pox In open-label, long-term safety studies of up to 4 years’ duration, the adverse event profile of tacrolimus ointment was similar to the adverse event profile seen in pivotal Phase 3 studies.
Maintenance In the two Phase 3, multi-centre, double-blind, vehicle-controlled 12-month studies the nature and incidence of adverse events were consistent with the established saf ety profile of tacrolimus ointment. Table 2 describes the most frequently reported adverse events (≥3%) that occurred in the Phase 3 study in adults.
PrLEO Pharma - Tacrolimus […]
Immune In clinical studies, cases of lymphadenopathy were reported and were usually related to infections and noted to resolve upon appropriate antibiotic therapy. The majority of these cases had either a clear etiology or were known to resolve.
g. systemic tacrolimus) are at increased risk for developing lymphoma; therefore, patients who receive LEO Pharma - Tacrolimus and who develop lymphadenopathy should have the etiology of their lymphadenopathy investigated. In the absence of a clear etiology for the lymphadenopathy or in the presence of acute infectious mononucleosis, discontinuation of LEO Pharma – Tacrolimus should be considered.
Patients who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves. Immunocompromised Patients The safety and efficacy of LEO Pharma - Tacrolimus in immunocompromised patients have not been studied.
Renal Insufficiency Post-marketing cases of acute renal failure have been reported in patients treated with LEO Pharma - Tacrolimus. Systemic absorption is more likely to occur in patients with epidermal barrier defects especially when LEO Pharma – Tacrolimus is applied to large body surface areas.
Caution should also be exercised in patients predisposed to renal impairment. Sexual Health Reproduction Reproductive toxicology studies were not performed with tacrolimus ointment. In studies of oral tacrolimus no impairment of fertility was seen in male and female rats.
0 mg/kg to male and female rats, prior to and during mating, as well as to dams during gestation and lactation, was associated with embryolethality and with adverse effects on female reproduction. Effects on female reproductive function (parturition) and embryolethal effects were indicated by a higher rate of pre-implantation loss and increased numbers of undelivered and nonviable pups.
2 mg/kg, tacrolimus was associated with maternal and paternal toxicity as well as reproductive toxicity including marked adverse effects on estrus cycles, parturition, pup viability, and pup malformations. Skin The use of LEO Pharma - Tacrolimus may cause local symptoms of short duration, such as skin burning (burning sensation, stinging, soreness) or pruritus.
Localized symptoms are most common during the first few days of LEO Pharma - Tacrolimus application and typically resolve as the lesions of atopic dermatitis heal. LEO Pharma - Tacrolimus has not been studied for its efficacy and safety in the treatment of clinically infected atopic dermatitis.
Patients with atopic dermatitis are predisposed to superficial PrLEO Pharma - Tacrolimus Page 8 of 33 skin infections. Treatment with LEO Pharma - Tacrolimus may be associated with an increased risk of varicella zoster virus infection (chickenpox or shingles), herpes simplex virus infection, or eczema herpeticum.
In the presence of infections, the balance of risks and benefits associated with LEO Pharma – Tacrolimus use should be evaluated. The enhancement of ultraviolet carcinogenicity is not necessarily dependent on phototoxic mechanisms. Despite the absence of observed phototoxicity in humans, LEO Pharma – Tacrolimus shortened the time to skin tumour formation in an animal photocarcinogenicity study (see Carcinogenesis, and Mutagenesis.
Therefore, it is prudent for patients to minimize or avoid natural or artificial sunlight exposure. The use of tacrolimus ointment is not recommended in patients with a skin barrier defect such as Netherton's syndrome, lamellar ichthyosis, generalized erythroderma or cutaneous […]