Zilxi

What Is Zilxi?

Zilxi (minocycline) is a tetracycline-class antibiotic used to treat inflammatory lesions of rosacea in adults.

What Are Side Effects of Zilxi?

Side effects of Zilxi may include:

• diarrhea,
• skin redness,
• spider veins,
• burning/stinging,
• flushing,
• dry skin,
• itching,
• skin peeling, and
• dark spots on skin (hyperpigmentation

Dosage for Zilxi

Apply Zilxi to affected areas once daily. Zilxi should be gently rubbed into the skin.

Zilxi In Children

The safety and effectiveness of Zilxi for the treatment of inflammatory lesions of rosacea have not been evaluated in pediatric patients.

What Drugs, Substances, or Supplements Interact with Zilxi?

Zilxi may interact with other medicines such as:

• anticoagulants and
• penicillin

Tell your doctor all medications and supplements you use.

Zilxi During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Zilxi; it may harm a fetus. The use of tetracycline class drugs orally during tooth development (second and third trimesters of pregnancy, infancy, and childhood up to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). Tetracycline-class drugs, including minocycline, pass into breast milk following oral administration. It is unknown if topically applied Zilxi passes into breast milk. Because of the potential for serious adverse reactions, breastfeeding is not recommended while using Zilxi.

Additional Information

Our Zilxi (minocycline) Topical Foam Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

 

Zilxi Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Serious side effects are unlikely when minocycline topical is applied to the skin, but can occur if the medicine is absorbed into your bloodstream.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);
• severe dizziness;
• confusion, headache, vision problems, pain behind your eyes;
• fever, swollen glands, itching, joint pain, or not feeling well;
• discoloration of your skin, nails, eyes, mouth, gums, or teeth.
• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• lupus-like symptoms--muscle or joint pain, flu symptoms, chest pain, and a rash or patchy skin color that worsens in sunlight.

Minocycline can affect growth in children, especially if used long term.

Common side effects may include:

• diarrhea; or
• headache.

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 Zilxi (Minocycline Topical Foam)

 

Zilxi 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In three (two Phase 3 and one Phase 2) multicenter, randomized, double-blind, vehicle-controlled trials, adult subjects applied ZILXI or vehicle once daily for 12 weeks. A total of 1,087 subjects were treated with ZILXI and 591 with vehicle. The majority of subjects were White (97%) and female (70%). Approximately 67% were non-Hispanic/Latino. The mean age was 50.0 years and ages ranged from 18 to 86 years.

The most common adverse reaction reported by ≥1% of subjects treated with ZILXI and more frequently than in subjects treated with vehicle was diarrhea (1% vs. 0%), respectively.

During the two Phase 3 trials, local tolerability evaluations were conducted at each study visit by assessment of erythema, telangiectasia, burning/stinging, flushing/blushing, dryness, itching, peeling and hyperpigmentation. Table 1 presents local tolerance assessments by incidence rate (%) and severity grade.

Subjects treated with ZILXI had improved local tolerability signs and symptoms at Week 12 when compared with corresponding baseline values. These occurred at a similar frequency and severity as subjects treated with the vehicle component of ZILXI.

Table 1: Facial Cutaneous Tolerability Assessment

	ZILXI, (%) (N=1,008**)
Symptom/Severity	Mild	Moderate	Severe
Erythema	36.2	18.3	0.7
Telangiectasia	61.0	18.8	0
Burning/Stinging	13.3	2.8	0
Flushing/Blushing	39.0	9.6	0.9
Dryness	23.9	4.0	0.1
Itching	20.0	3.3	0
Skin Peeling	16.1	1.9	0.1
Hyperpigmentation*	22.5	2.8	0
*Hyperpigmentation was most frequently assessed as characteristic of inflammatory and post-inflammatory changes associated with inflammatory lesions of rosacea. ** Of 1,008 subjects, 897 had local tolerability assessments at Week 12.

In a 40-week open-label extension safety study of ZILXI (for a total of up to 52 weeks of treatment) [NCT03276936], frequency and severity of local tolerability signs and symptoms at Week 52 were comparable to those reported at Week 12.

Read the entire FDA prescribing information for Zilxi (Minocycline Topical Foam)