Aklief
- Generic Name: trifarotene cream
- Brand Name: Aklief
Aklief (Trifarotene Cream) side effects drug center
Aklief Side Effects Center
What Is Aklief?
Aklief (trifarotene) Cream is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
What Are Side Effects of Aklief?
Common side effects of Aklief include:
- application site reactions such as:
- irritation,
- itching,
- pain,
- redness,
- dryness,
- stinging/burning,
- discoloration,
- rash,
- swelling, and
- lesions
- sunburn,
- acne, and
- allergic dermatitis
Dosage for Aklief
The dose of Aklief Cream is a thin layer applied to the affected areas of the face and/or trunk once a day, in the evening, on clean and dry skin.
What Drugs, Substances, or Supplements Interact with Aklief?
Aklief may interact with other drugs. Tell your doctor all medications and supplements you use.
Aklief During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Aklief it is unknown how it would affect a fetus. It is unknown if Aklief Cream passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Aklief (trifarotene) Cream, for Topical Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Aklief Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using trifarotene topical and call your doctor at once if you have:
- severe skin irritation (burning, stinging, scaling) after applying the medicine; or
- severe skin redness or dryness.
Common side effects may include:
- itching or other skin irritation; or
- sunburn.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Aklief (Trifarotene Cream)
Aklief Professional Information
SIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect rates observed in practice. In the three Phase 3 clinical trials, a total of 1673 subjects with acne vulgaris on the face and trunk, 9 years and older were exposed to AKLIEF Cream. Of these, 1220 subjects were treated once daily for up to 12 weeks and 453 were treated once daily for up to 1 year.
Adverse reactions reported in the 2 randomized, double-blind, vehicle-controlled 12-week clinical trials in ≥1.0% of subjects treated with AKLIEF Cream (and for which the rate exceeded the rate for vehicle), as well as the corresponding rates reported in subjects treated with the vehicle cream are presented in Table 1.
Table 1: Adverse Reactions Occurring in ≥ 1.0%
of Subjects with Acne Vulgaris of the Face and Trunk in the Two 12-week Phase 3
Clinical Trials
| Preferred Term | AKLIEF Cream (N= 1220) |
Vehicle Cream (N=1200) |
| Application site irritation | 91 (7.5) | 4 (0.3) |
| Application site pruritus | 29 (2.4) | 10 (0.8) |
| Sunburn | 32 (2.6) | 6 (0.5) |
Additional adverse reactions that were reported in more than one subject treated with AKLIEF Cream (and at a frequency <1%) included application site pain, application site dryness, application site discoloration, application site rash, application site swelling, application site erosion, acne, dermatitis allergic, and erythema.
In the one-year, open-label safety trial that included 453 subjects 9 years and older, with acne vulgaris of the face and trunk, the pattern of adverse reactions for AKLIEF Cream was similar to that experienced in the 12-week controlled trials. A total of 12.6% of subjects had at least one adverse reaction during the trial, and 2.9% of subjects had an adverse reaction leading to treatment discontinuation. The most common adverse reactions (≥ 1% of subjects) for the entire trial were application site pruritus (4.6%), application site irritation (4.2%), and sunburn (5.5%). The frequency of adverse reactions decreased over time.
Skin irritation was evaluated by active assessment of erythema, scaling, dryness, and stinging/burning and collected separately. In the two 12-week Phase 3 clinical trials, these signs/symptoms were assessed at baseline and at least one post-baseline visit, in 1214 subjects (for face) and 1202 subjects (for trunk) treated with AKLIEF Cream. The percentage of subjects who were assessed to have these signs and symptoms at any post baseline visit and at a severity worse than baseline are summarized in Table 2.
Table 2: Application Site Tolerability Reactions at
Any Post Baseline Visit
| Face | AKLIEF N=1214 Maximum Severity during Treatment |
Vehicle Cream N= 1194 Maximum Severity during Treatment |
||||
| Mild | Moderate | Severe | Mild | Moderate | Severe | |
| Erythema | 30.6% | 28.4% | 6.2% | 21% | 6.8% | 0.8% |
| Scaling | 37.5% | 27.1% | 4.9% | 23.7% | 5.9% | 0.3% |
| Dryness | 39% | 29.7% | 4.8% | 29.9% | 6.8% | 0.8% |
| Stinging/Burning | 35.6% | 20.6% | 5.9% | 15.9% | 3.8% | 0.5% |
| Trunk | N=1202 | N=1185 | ||||
| Erythema | 26.5% | 18.9% | 5.2% | 12.7% | 4.4% | 0.4% |
| Scaling | 29.7% | 13.7% | 1.7% | 13.2% | 2.6% | 0.1% |
| Dryness | 32.9% | 16.1% | 1.8% | 17.8% | 3.9% | 0.1% |
| Stinging/Burning | 26.1% | 10.9% | 4.3% | 9.2% | 2.2% | 0.5% |
Local tolerability on the face in subjects treated with AKLIEF Cream worsened for any of the signs/symptoms compared with baseline to a score of moderate for up to 30% of subjects, or severe for up to 6% of subjects. On the trunk, the corresponding percentages were up to 19% (moderate) and up to 5% (severe). The scores reached maximum severity at Week 1 for the face, and at Week 2 to 4 of treatment for the trunk, and decreased thereafter.
In the open-label, 1-year Phase 3 trial, the local tolerability profile was comparable to that observed in the two pivotal Phase 3 trials.
Read the entire FDA prescribing information for Aklief (Trifarotene Cream)
© Aklief Patient Information is supplied by Cerner Multum, Inc. and Aklief Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.