Aldara

Name: Aldara

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Indications

Actinic Keratosis

Aldara Cream is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults.

Superficial Basal Cell Carcinoma

Aldara Cream is indicated for the topical treatment of biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults, with a maximum tumor diameter of 2.0 cm, located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured.

The histological diagnosis of superficial basal cell carcinoma should be established prior to treatment, since safety and efficacy of Aldara Cream have not been established for other types of basal cell carcinomas, including nodular and morpheaform (fibrosing or sclerosing) types.

External Genital Warts

Aldara Cream is indicated for the treatment of external genital and perianal warts/condyloma acuminata in patients 12 years old or older.

Limitations Of Use

Aldara Cream has been evaluated in children ages 2 to 12 years with molluscum contagiosum and these studies failed to demonstrate efficacy [see Use In Specific Populations].

Unevaluated Populations

The safety and efficacy of Aldara Cream in immunosuppressed patients have not been established.

Aldara Cream should be used with caution in patients with pre-existing autoimmune conditions.

The efficacy and safety of Aldara Cream have not been established for patients with Basal Cell Nevus Syndrome or Xeroderma Pigmentosum.

Aldara Dosage

Apply Aldara cream exactly as prescribed. Follow the directions on your prescription label carefully.

For external genital and perianal warts, Aldara (imiquimod) cream is usually used once a day for 3 days a week for 16 weeks.

For actinic keratosis, Aldara (imiquimod) cream is usually used once a day for 2 days a week, 3 to 4 days apart for 16 weeks.

For superficial basal cell carcinoma, Aldara (imiquimod) cream is usually used once a day for 5 days a week for 6 weeks.

Leave the cream on the affected area or areas for the time your doctor recommends. The length of time that Aldara cream is left on the skin is not the same for the different skin conditions that Aldara cream is used to treat. Do not bathe or get the treated area wet before the right time has passed. Do not leave Aldara cream on your skin longer than prescribed.

Pharmacology

Mechanism of Action

Unknown mechanism in treating actinic keratosis and external genital warts; immune response modifier, stimulates release of inflammatory cytokines and proliferation/migration of immune cells

No direct antiviral activity

Absorption

Appears to be dependent on area of application rather than amount applied

Peak plasma concentration (Aldara): 0.1-3.5 ng/mL

Peak plasma concentration (Zyclara): 0.323 ng/mL

Elimination

Excretion: Urine

Imiquimod topical side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Wash off the medicine and call your doctor at once if you have a serious skin reaction such as severe itching, burning, oozing, bleeding, or skin changes where the medicine is applied.

Stop using imiquimod topical and call your doctor at once if you have a serious side effect such as flu symptoms such as fever, chills, body aches, tired feeling, swollen glands.

When treating genital warts around the vagina, if you have severe swelling or urination problems, stop using imiquimod topical and call your doctor right away.

Less serious side effects may include:

  • mild skin irritation, itching, dryness, flaking, scabbing, crusting, redness, or hardening of the skin where the medicine was applied;

  • changes in the color of treated skin;

  • headache, dizziness, chest pain, back pain;

  • cold sores, fever blisters;

  • cold symptoms such as stuffy nose, sneezing, sore throat;

  • nausea, diarrhea, loss of appetite; or

  • vaginal itching or discharge.

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.

Actions

  • Mechanism of action in topical treatment of actinic keratosis or superficial basal cell carcinoma unknown.1

  • Topical application to superficial basal cell carcinoma may increase infiltration of lymphocytes, dendritic cells, and macrophages into the tumor lesion; clinical importance unknown.1

  • The exact mechanism(s) of action of imiquimod in the topical treatment of exophytic HPV warts has not been elucidated, but may be related to the immunomodulating effects of the drug.1 23 25 26 Imiquimod induces production of a variety of cytokines6 20 23 and apparently can enhance cell-mediated cytolytic antiviral activity.2 7

  • In vitro in cell culture, imiquimod has no direct antiviral activity against HPV.1 6 7 26

  • Imiquimod is a rapid6 and potent inducer of IFN-α,2 6 7 20 21 23 interleukin-1 alpha and beta (IL-1α and IL-1β),2 6 interleukin-6 (IL-6),2 6 interleukin-8 (IL-8),2 tumor necrosis factor alfa (TNF-α),2 6 23 granulocyte-macrophage colony-stimulating factor (GM-CSF),6 granulocyte colony-stimulating factor (G-CSF),6 and macrophage inflammatory protein-1α.6

Uses of Aldara

  • It is used to treat genital warts.
  • It is used to treat perianal warts.
  • It is used to treat skin harmed by the sun and some skin cancers.

What is Aldara?

Aldara (imiquimod) is an immune response modifier. Aldara is used to treat actinic keratosis (a condition caused by too much sun exposure) on the face and scalp.

Aldara (for the skin) is also used to treat a minor form of skin cancer called superficial basal cell carcinoma, when surgery would not be an appropriate treatment.

Aldara also treats genital warts that appear on the outside of the body, but this medicine is not a cure for genital warts. Imiquimod may be used in adults and children who are at least 12 years.

Aldara may also be used for purposes not listed in this medication guide.

What happens if I miss a dose?

Skip the missed dose and wait until the next time you are getting ready for bed to use the medicine. Do not use extra medicine to make up the missed dose.

In Summary

Common side effects of Aldara include: dermal ulcer, application site reaction, burning sensation, desquamation, edema, excoriation, exfoliation of skin, pruritus, skin erosion, and erythema. Other side effects include: back pain, headache, and pain. See below for a comprehensive list of adverse effects.

For Healthcare Professionals

Applies to imiquimod topical: topical cream

General

In general, the side effects associated with imiquimod topical (the active ingredient contained in Aldara) may vary depending on the condition being treated.[Ref]

Local

Local skin reactions were recorded as adverse reactions only if they extended beyond the treatment area, if they required any medical intervention, or they resulted in patient discontinuation from a study.

In studies involving treatment of actinic keratosis or superficial basal cell carcinoma, the dermatologic side effects classified as local and application site most frequently resulted in clinical intervention (e.g., rest periods, withdrawal from study, treatment site infections requiring treatment with antibiotics).

Flaking/scaling was reported in 40% of males and 26% of females and scabbing/crusting was reported in 34% of males and 18% of females; otherwise, frequency and severity of local skin reactions were similar in both genders.[Ref]

Local side effects have included application site reaction (up to 33%), application site pain (up to 7%), application site irritation (up to 6%), application site pruritus (up to 4%), application site bleeding, application site swelling, treatment site infection, scarring, application site rash, application site cellulitis, and application site excoriation. Local skin reactions have included erythema (all grades: up to 100%; severe: up to 31%), scabbing/crusting (all grades: up to 93%; severe: up to 19%), flaking/scaling/dryness (all grades: up to 93%; severe: up to 8%), flaking/scaling (all grades: 91% ; severe: 4%), induration (all grades: up to 84% ; severe: up to 6%), edema (all grades: up to 78%; severe: up to 7%), erosion (all grades: up to 66% ; severe: up to 14%), erosion/ulceration (all grades: up to 62%; severe: up to 13%), exudate (all grades: up to 51%; severe: 6%), ulceration (all grades: up to 40% ; severe: up to 6%), weeping/exudate (all grades: up to 22%), vesicles (all grades: up to 31%; severe: up to 2%), excoriation/flaking (all grades: up to 26%; severe: up to 1%), and scabbing (all grades: up to 13%). Application site reactions have included itching (up to 20%), burning (6%), bleeding (up to 3%), stinging (3%), pain (3%), erythema (2%), papule(s) (2%), induration (2%), tenderness (up to 2%), irritation (2%), and infection (1%). Application site disorders reported in more than 1% of patients have included burning, hypopigmentation, rash, sensitivity, soreness, stinging, and tenderness. Itching (32% in females, 22% in males), burning (26% in females, 9% in males), pain (8% in females, 2% in males), and soreness (3% in females) were reported at the wart site. Tingling at the application site has been reported during postmarketing experience.[Ref]

Respiratory

Respiratory side effects have included upper respiratory tract infection (up to 15%), sinusitis (up to 7%), rhinitis (3%), coughing (2%), and pharyngitis (1%). Pulmonary congestion and bronchitis have been reported. Dyspnea and pulmonary edema have been reported during postmarketing experience.[Ref]

Immunologic

Immunologic side effects have included fungal infection (11% in females, 2% in males), herpes simplex (up to 3%), oral herpes (up to 3%), viral infection (1%), herpes zoster, and infection. Herpes simplex has also been reported during postmarketing experience.[Ref]

Nervous system

Two cases involving the development of chronic neuropathic pain following initiation of imiquimod topical (the active ingredient contained in Aldara) therapy for the treatment of warts have been reported. In the first case, a 53-year-old man with genital warts reported an erosion with substantial pain on the left lateral glans of the penis approximately 1 week following initiation of therapy with imiquimod applied topically 3 times a week. Imiquimod therapy was discontinued; however, the patient continued to report a burning-like pain and erythema in the area for approximately 2 years. The condition may have been exacerbated by aerobic exercise, sweating, and sexual activity. In the second case report, a 64-year-old woman with plantar warts developed numbness and pain in all toes and the balls of both feet following approximately 5 months of therapy with imiquimod topical applied each night with tape occlusion. Imiquimod topical was discontinued. This condition may have been exacerbated by a daily paring of the warts by the patient prior to imiquimod application. Approximately 2 years later, the patient reported a gradual improvement in the numbness and an absence of the burning-like pain. Neither patient had diabetes mellitus, or any other condition known to result in possible neuropathic pain.[Ref]

Nervous system side effects have included headache (up to 8%), dizziness (up to 3%), insomnia, and lethargy. Nervous system side effects have rarely included neuropathic pain. Agitation, convulsions (including febrile convulsions), insomnia, multiple sclerosis aggravation, and paresis have been reported during postmarketing experience.[Ref]

Other

Other side effects have included back pain (up to 4%), fatigue (up to 4%), influenza-like illness (up to 4%), pyrexia (up to 3%), pain (up to 3%), influenza-like symptoms (3% in females, 1% in males), rigors (1%), and chills. Hernia, inflicted injury, and postoperative pain have been reported.[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea (up to 4%), anorexia (up to 3%), diarrhea (up to 3%), dyspepsia (2%), cheilitis (up to 2%), and vomiting (up to 1%). Gastrointestinal disorder and aphthous ulcers (rare) have been reported. Abdominal pain has been reported during postmarketing experience.[Ref]

A review of 3 case reports involving patients receiving imiquimod topical applied 2 or 3 times weekly for treatment of actinic cheilitis in the lip region reported the formation of aphthous ulcers approximately 2 to 3 weeks following initiation of treatment. In each case, the aphthous ulcers resolved upon discontinuation of imiquimod topical and treatment with a topical steroid. None of the patients consented to a rechallenge.[Ref]

Oncologic

An 87-year-old Caucasian woman developed invasive amelanotic melanoma with satellite lesions within 14 weeks after initiation of treatment with imiquimod three times per week. It is unknown if this was a probable side effect of imiquimod or a progressive event of melanoma in situ.[Ref]

Oncologic side effects have included squamous cell carcinoma (up to 4%). Basal cell carcinoma has been reported. Oncologic side effects reported during non-FDA approved treatment of melanoma in situ have included a single case report of the development of invasive melanoma.[Ref]

Hematologic

Hematologic side effects have included lymphadenopathy (up to 3%) and pancytopenia. Decreases in red cell, white cell, and platelet counts (including idiopathic thrombocytopenic purpura), and lymphoma have been reported during postmarketing experience.[Ref]

Cardiovascular

Cardiovascular side effects have included chest pain (up to 2%), atrial fibrillation (1%), and hypertension. Capillary leak syndrome, cardiac failure, cardiomyopathy, cerebrovascular accident, arrhythmias (tachycardia, supraventricular tachycardia, atrial fibrillation, palpitations), chest pain, ischemia, myocardial infarction, syncope, and Henoch-Schonlein purpura syndrome have been reported during postmarketing experience.[Ref]

Dermatologic

In the studies involving treatment of genital/perianal warts, the skin reactions reported were more frequent and more intense with daily application of the cream than with the application of the cream three times per week.

In studies involving treatment of actinic keratosis or superficial basal cell carcinoma, the dermatologic side effects classified as local and application site most frequently resulted in clinical intervention (e.g., rest periods, withdrawal from study, treatment site infections requiring treatment with antibiotics).[Ref]

Dermatologic side effects have included eczema (2%), alopecia (1%), dermatitis, and pruritus. Remote site skin reaction were reported and included erythema (3% in females, 1% in males), ulceration (2% in females), erosion (2% in males), edema (1% in females, 1% in males), induration (1% in males), and excoriation/flaking (1% in males). Remote site reactions reported in more than 1% of patients have included bleeding, burning, itching, pain, tenderness, and tinea cruris. Hyperkeratosis, rash, skin disorder, photosensitivity reaction, verruca, and remote site irritation have been reported. Imiquimod-induced psoriasis and at least 1 case each of vitiligo-like hyperpigmentation, contact pemphigus, pityriasis rubra pilaris exacerbation, erosive pustular dermatosis of the scalp, and eruptive keratoacanthoma have been reported. Exfoliative dermatitis, erythema multiforme, hyperpigmentation, hypopigmentation, and hypertrophic scar have been reported during postmarketing experience.[Ref]

Musculoskeletal

Musculoskeletal side effects have included arthralgia (up to 3%) and myalgia (up to 1%). Arthritis and skeletal pain have been reported. Arthralgia has also been reported during postmarketing experience.[Ref]

Genitourinary

Genitourinary side effects have included bacterial vaginitis (up to 3% of females), urinary tract infections (1%), scrotal pain, scrotal erythema, scrotal ulcer, and scrotal edema. Proteinuria, urinary retention, and dysuria have been reported during postmarketing experience.[Ref]

Psychiatric

Psychiatric side effects have included anxiety (1%). Depression and suicide have been reported during postmarketing experience.[Ref]

Ocular

Ocular side effects have included conjunctivitis and eye abnormality.[Ref]

Hypersensitivity

Hypersensitivity side effects have included angioedema during postmarketing experience. Aggravation of allergy has been reported.[Ref]

A 61-year-old man developed angioedema 3 weeks into treatment for squamous cell carcinoma in situ located on the right forearm. One week prior he had developed ulceration over the application site. The angioedema started in the right hand at which time the imiquimod therapy was discontinued. Within 36 hours of discontinuation the angioedema had encompassed both hands and feet and the ulcerated application site. Fifty-four hours following discontinuation of therapy the patient was awakened by severe swelling of the tongue, diagnosed by the emergency room physician as angioedema of the tongue. The patient experienced difficulty talking and swallowing, but no respiratory distress. The patient denied presence of chills, fever, or influenza-like symptoms. The patient denied history of urticaria, angioedema, or anaphylaxis. The patient was stable on all medications prior to initiation of imiquimod therapy. The patient improved following treatment with intravenous diphenhydramine and methylprednisolone. It is thought that the large application site (16.7 m2) and the ulceration may have facilitated in the absorption of imiquimod resulting in the angioedema.[Ref]

Metabolic

Metabolic side effects have included hypercholesterolemia and gout.[Ref]

Hepatic

Hepatic side effects have included abnormal liver function during postmarketing experience.[Ref]

Endocrine

Endocrine side effects have included thyroiditis during postmarketing experience.[Ref]

Some side effects of Aldara may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

(web3)