Drug name: Zyclara (Topical)

Description:

Zyclara (Topical)

Generic name: imiquimod (topical route) [ im-I-kwi-mod ]
Drug classes: Topical anti-infectives, Topical antineoplastics

Medically reviewed by Drugs.com. Last updated on Dec 18, 2022.

Commonly used brand name(s)

In the U.S.

  • Aldara
  • Zyclara

Available Dosage Forms:

  • Cream

Therapeutic Class: Immune Modulator

Uses for Zyclara

Imiquimod topical is used to treat external warts around the genital and rectal areas called condyloma acuminatum. It is not used on warts inside the vagina, penis, or rectum. Imiquimod is also used to treat a skin condition of the face and scalp called actinic keratosis (AK), which is caused by too much sun exposure. Imiquimod may be used to treat certain types of skin cancer called superficial basal cell carcinoma (sBCC).

Imiquimod works on the immune system to help the body fight viruses that cause warts. It does not destroy the viruses directly. It is not known how imiquimod works for actinic keratosis or skin cancer.

This medicine is available only with your doctor''s prescription.

Before using Zyclara

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of imiquimod topical for external warts in children older than 12 years of age. However, safety and efficacy have not been established in children younger than 12 years of age.

Appropriate studies on the relationship of age to the effects of imiquimod topical for actinic keratosis or skin cancer have not been performed in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of imiquimod topical in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Autoimmune disorders, history of or
  • Infection of the skin at or near the place of application or
  • Large sores, broken skin, or severe skin injury at the place of application or
  • Rheumatoid arthritis, juvenile or adult (chronic, always present) or
  • Sun exposure, including sunlamps or
  • Surgery, recent, at the place of application or
  • Systemic lupus erythematosus (SLE), history of or
  • Vulvar swelling (swelling near the opening of the vagina)—The chance of side effects may be increased.
  • Basal cell nervus syndrome or
  • Human papilloma viral disease (cervical, intra-anal, intravaginal, rectal, urethral) or
  • Weak immune system or
  • Xeroderma pigmentosum (a rare, inherited skin disease)—It is not known if this medicine will work in patients with these conditions.

Proper use of Zyclara

This section provides information on the proper use of a number of products that contain imiquimod. It may not be specific to Zyclara. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, vagina, or anus. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

If you are using the Zyclara® cream pump for the first time, prime it by pressing the top of the pump until the cream appears.

To use the cream:

  • Wash your hands with soap and water before and after using the medicine.
  • Use one or two packets or actuations of the pump of cream for each dose as directed by your doctor.
  • Apply a thin layer to the affected area of the skin just before bedtime. Rub it in gently.
  • Allow the medicine to stay on the treated skin for 8 hours (for actinic keratosis or basal cell carcinoma) or 6 to 10 hours (for genital warts). Do not take a bath, swim, or get the treated area wet during this time.
  • After the right amount of time has passed, wash the treated area with mild soap and water.
  • Men who are not circumcised and are treating genital warts under the foreskin should retract the foreskin and clean the area daily.
  • Do not bandage or otherwise wrap the skin being treated, unless directed to do so by your doctor. Materials that are not airtight, such as cotton gauze or cotton underwear, may be used if needed.
  • Throw out any unused cream from the single-dose packet.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Do not use this medicine together with any other products containing imiquimod in the same treatment area. This may increase risk for more serious side effects.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor''s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For topical dosage form (cream):
    • For actinic keratosis:
      • Adults—If you use Zyclara®, apply a thin film to the affected area of skin once a day at bedtime for 2 weeks. Your doctor will repeat the treatment after you go 2 weeks without medicine. If you use Aldara®, apply a thin film to the affected area of skin once a day at bedtime 2 times per week for 16 weeks. Your doctor will tell you which days are best during the week.
      • Children—Use and dose must be determined by your doctor.
    • For skin cancer:
      • Adults—Apply a thin film to the affected area of skin once a day at bedtime 5 times per week for 6 weeks. Your doctor will tell you which days are best during the week.
      • Children—Use and dose must be determined by your doctor.
    • For external warts:
      • Adults and children 12 years of age and older—If you use Zyclara®, apply a thin film to the wart once a day at bedtime for up to 8 weeks or until the wart is gone. If you use Aldara®, apply a thin film to the wart once a day at bedtime 3 times per week. Your doctor will tell you which days are best during the week. Use the medicine until the wart is gone, but for no longer than 16 weeks.
      • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the Zyclara® cream pump upright.

Detailed Zyclara dosage information

Precautions while using Zyclara

It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, pain, redness, swelling, bleeding, oozing, scabbing, or peeling on the skin where the medicine was applied.

Stop using this medicine and check with your doctor right away if you have severe swelling near the opening of the vagina. This may cause painful urination, trouble in passing urine, or not able to urinate.

Stop using this medicine and check with your doctor right away if you or your child have severe skin irritation or flu-like symptoms, such as diarrhea, fever, chills, headache, nausea, muscle or joint pain, or unusual tiredness or weakness.

Avoid exposing your skin to sunlight, sunlamps, or tanning beds while you are using this medicine. Always use sunscreen or sun-blocking lotions and wear protective clothing and hats.

If you are being treated for external warts, avoid having genital, oral, or anal sex while the medicine is on your skin. Make sure you wash the cream off your skin before you engage in any sexual activity. The medicine contains oils that can weaken latex (rubber) condoms and diaphragms, which will prevent them from working properly.

Imiquimod is not a cure for genital warts. New warts may develop while you are using the cream. Imiquimod will also not keep you from spreading genital warts to other people.

Do not use cosmetics or any other skin care products on the treated areas, unless directed to do so by your doctor.

Zyclara side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  • Blisters on the skin
  • body aches or pain
  • chills
  • cough
  • difficulty with breathing
  • ear congestion
  • itching in the genital or other skin areas
  • loss of voice
  • open sores or scabs on the skin
  • pain or tenderness around the eyes and cheekbones
  • redness of the skin (severe)
  • scaling
  • shortness of breath or troubled breathing
  • skin rash
  • sneezing
  • sore throat
  • stuffy or runny nose
  • tightness of the chest or wheezing
  • unusual tiredness or weakness

Less common

  • Abdominal or stomach pain
  • ankle, knee, or great toe joint pain
  • bladder pain
  • bloody or cloudy urine
  • blurred vision
  • chest pain
  • cold flu-like symptoms
  • difficult, burning, or painful urination
  • dizziness
  • fainting
  • fast or irregular heartbeat
  • frequent urge to urinate
  • hoarseness
  • joint stiffness or swelling
  • lower back or side pain
  • lump in the abdomen or stomach
  • nervousness
  • persistent non-healing sore
  • pink growth on the skin
  • pounding in the ears
  • reddish patch or irritated area
  • severe headache
  • shiny bump on the skin
  • slow or fast heartbeat
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • white, yellow or waxy scar-like area

Incidence not known

  • Blue lips and fingernails
  • convulsions
  • coughing that sometimes produces a pink frothy sputum
  • dilated neck veins
  • extreme fatigue
  • fast, irregular, or pounding heartbeat
  • headache
  • irregular breathing
  • nausea or vomiting
  • pain in the shoulders, arms, jaw, or neck
  • slurred speech
  • sudden and severe inability to speak
  • suicide
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • temporary blindness
  • weakness in the arm or leg on one side of the body
  • weight gain

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  • Confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Burning or stinging of the skin (mild)
  • flaking of the skin
  • mild headache
  • pain, soreness, or tenderness of the skin (mild)
  • rash
  • redness of the skin (mild)
  • swelling at place of application

Less common

  • Back pain
  • lightening of the treated skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Zyclara side effects (more detail)

Frequently asked questions

  • Is imiquimod the same as Aldara?
  • What are the side effects of the HPV vaccine?
  • Does Zyclara work for genital warts?
  • Who makes Zyclara and where is it manufactured?

More about Zyclara (imiquimod topical)

  • Check interactions
  • Pricing & coupons
  • Reviews (48)
  • Side effects
  • Dosage information
  • During pregnancy
  • Generic availability
  • FDA approval history
  • Drug class: topical anti-infectives
  • Breastfeeding

Patient resources

  • Drug Information

Other brands

Aldara

Professional resources

  • Prescribing Information

Related treatment guides

  • Condylomata Acuminata
  • Keratosis

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

','2023-03-10 21:39:10','2023-03-10 21:39:10'); INSERT INTO `default`.drags_translation (drag_id,language_id,title,content,created_at,updated_at) VALUES (15752,3,'Zydelig','

Zydelig

Generic name: idelalisib [ eye-DEL-a-LIS-ib ]
Drug class: PI3K inhibitors

Medically reviewed by Philip Thornton, DipPharm. Last updated on Nov 28, 2022.

What is Zydelig?

Zydelig is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Zydelig is used together with rituximab (Rituxan) to treat chronic lymphocytic leukemia, and certain types of lymphoma.

Zydelig is sometimes given after at least two other cancer treatments did not work or have stopped working.

Zydelig was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis to treat lymphoma. In clinical studies, some people responded to this medicine, but further studies are needed.

Warnings

Zydelig can cause serious harm to your liver, lungs, or intestines. Some of these conditions may lead to fatal complications. Call your doctor right away if you have: upper stomach pain, easy bruising or bleeding, dark urine, yellowing of your skin or eyes, cough, wheezing, shortness of breath, fever, chills, worsening stomach pain, or vomiting.

You may have severe or life-threatening diarrhea while taking Zydelig. Tell your doctor at once if your daily bowel movements increase by 6 or more. Zydelig can also cause a perforation (a hole or tear) in your intestines. Call your doctor at once if you have diarrhea that is watery or bloody, if you have bloody or tarry stools, or if you cough up blood that looks like coffee grounds.

Before taking this medicine

You may not be able to use Zydelig if you have ever had a serious skin reaction to any medicine.

To make sure Zydelig is safe for you, tell your doctor if you have ever had:

  • liver disease;

  • lung disease; or

  • a perforation (a hole or tear) in your intestines.

Idelalisib can harm an unborn baby if the mother or the father is using this medicine.

  • If you are a woman, do not use Zydelig if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 month after your last dose.

  • If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

  • Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Zydelig.

Do not breastfeed while using this medicine, and for at least 1 month after your last dose.

Zydelig is not approved for use by anyone younger than 18 years old.

Zydelig pregnancy and breastfeeding warnings (more detail)

How should I take Zydelig?

Zydelig is usually taken twice per day. Follow all directions on your prescription label and read all medication guides or instruction sheets.

You may take Zydelig with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

You may have severe or life-threatening diarrhea while taking Zydelig. Tell your doctor at once if your daily bowel movements increase by 6 or more.

You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.

Do not stop using Zydelig without your doctor''s advice.

Store this medicine in the original container at room temperature, away from moisture and heat.

Dosing information

Usual Adult Dose of Zydelig for non-Hodgkin''s Lymphoma:

150 mg orally 2 times a day until disease progression or unacceptable toxicity

Comments:
-This drug can be taken with or without food.
-Tablets should be swallowed whole.
-If the patient misses a dose within 6 hours of the time it is usually taken, the patient should take the missed dose as soon as possible and resume the normal dosing schedule.
-If a patient misses a dose by more than 6 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.

Uses:
-In combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.
-The treatment of patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) who have received at least 2 prior systemic therapies.
-The treatment of patients with relapsed small lymphocytic lymphoma (SLL) who have received at least 2 prior systemic therapies.

Usual Adult Dose of Zydelig for Chronic Lymphocytic Leukemia:

150 mg orally 2 times a day until disease progression or unacceptable toxicity

Comments:
-This drug can be taken with or without food.
-Tablets should be swallowed whole.
-If the patient misses a dose within 6 hours of the time it is usually taken, the patient should take the missed dose as soon as possible and resume the normal dosing schedule.
-If a patient misses a dose by more than 6 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.

Uses:
-In combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.
-The treatment of patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) who have received at least 2 prior systemic therapies.
-The treatment of patients with relapsed small lymphocytic lymphoma (SLL) who have received at least 2 prior systemic therapies.

Usual Adult Dose of Zydelig for Lymphoma:

150 mg orally 2 times a day until disease progression or unacceptable toxicity

Comments:
-This drug can be taken with or without food.
-Tablets should be swallowed whole.
-If the patient misses a dose within 6 hours of the time it is usually taken, the patient should take the missed dose as soon as possible and resume the normal dosing schedule.
-If a patient misses a dose by more than 6 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.

Uses:
-In combination with rituximab, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.
-The treatment of patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) who have received at least 2 prior systemic therapies.
-The treatment of patients with relapsed small lymphocytic lymphoma (SLL) who have received at least 2 prior systemic therapies.

Detailed Zydelig dosage information

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if you are more than 6 hours late for the dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What to avoid

Follow your doctor''s instructions about any restrictions on food, beverages, or activity.

Zydelig side effects

Get emergency medical help if you have signs of an allergic reaction to Zydelig (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.

Zydelig can cause serious harm to your liver, lungs, or intestines. You may have severe or life-threatening diarrhea, or a perforation (a hole or tear) in your intestines. Some of these conditions may lead to fatal complications.

Call your doctor at once if you have:

  • severe diarrhea, increased number of stools per day;

  • easy bruising, unusual bleeding, purple or red spots under your skin;

  • intestinal problems - worsening stomach pain, fever, chills, vomiting;

  • liver problems - upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);

  • lung problems - worsening cough, wheezing, cough with mucus, or shortness of breath;

  • low white blood cell counts - fever, mouth sores, skin sores, sore throat.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Zydelig side effects may include:

  • nausea, stomach pain, diarrhea;

  • fever, cough, lung problems;

  • low white blood cells;

  • abnormal liver function tests;

  • rash; or

  • feeling tired.

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.

Zydelig side effects (more detail)

What other drugs will affect Zydelig?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with idelalisib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Zydelig drug interactions (more detail)

Where can I get more information?

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Zydelig only for the indication prescribed.

Popular FAQ

Is Zydelig a chemotherapy drug?

Zydelig (idelalisib) is not a chemotherapy drug, but a targeted anticancer treatment taken twice daily by mouth. Targeted drug therapies like Zydelig work by blocking specific pathways that allow the cancer to grow uncontrolled. Zydelig is used in combination with rituximab (Rituxan) to treat chronic lymphocytic leukemia (CLL). Continue reading

What is Zydelig used for and how does it work?

In the United States, Zydelig is approved to treat relapsed chronic lymphocytic leukemia (CLL) in combination with rituximab, where rituximab is appropriate to use taking into account other health conditions a person may have. Continue reading

More about Zydelig (idelalisib)

  • Check interactions
  • Compare alternatives
  • Pricing & coupons
  • Reviews (2)
  • Drug images
  • Side effects
  • Dosage information
  • Patient tips
  • During pregnancy
  • FDA approval history
  • Drug class: PI3K inhibitors
  • Breastfeeding
  • En español

Professional resources

  • Prescribing Information

Related treatment guides

  • Chronic Lymphocytic Leukemia
  • Follicular Lymphoma
  • Lymphoma
  • Non-Hodgkin''s Lymphoma

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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