What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Hanzema (Alitretinoin)
Prescription Required
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Product Details
Description
Hanzema is a medication that contains a retinoid called alitretinoin, which is a synthetic derivative of vitamin A. The drug works by altering the activity of DNA in skin cells, which may help reduce inflammation and help skin to heal. Specifically, Hanzema targets severe chronic hand eczema that is resistant to other treatments, including high-potency corticosteroids. Patients take Hanzema when other methods, such as skin protection and avoiding irritants, haven't managed to control symptoms.
Fact Table
Formula
C20H28O2
License
Health Canada, EMA
Bioavailability
About 40% (oral, with a high-fat meal)
Legal status
Prescription only (Rx)
Chemical Name
9-cis-Retinoic acid
Elimination half-life
2–10 hours
Dosage (Strength)
10 mg, 30 mg (oral capsules)
Pregnancy
Contraindicated
Brands
Hanzema, Toctino
Protein binding
99.9%
PubChem CID
449700
MedlinePlus
a682005
ChEBI
38922
ATC code
D05BB04
DrugBank
DB00523
KEGG
D02837
Routes of administration
Oral, Topical
Directions
Hanzema is typically taken once daily. Follow a physician's instructions closely, starting with the usual dose being a 30 mg capsule. Swallow the capsule whole, not chewed or crushed. The medication can be taken with or without food. The treatment could be for several weeks before any effect is noticed.
While on Hanzema, avoid taking vitamin A supplements to prevent a potential overdose. It's also imperative to keep in mind that dosage may vary based on individual response and clinical condition, so regular follow-up with the healthcare provider is key.
Ingredients
The primary ingredient in Hanzema is alitretinoin.
Contraindications
Avoid taking or using this medication if any of the following apply:
- Pregnancy: Hanzema is contraindicated due to the risk of birth defects.
- Breastfeeding: The effects on infants are not well established, and potential risks should be weighed.
- Known allergy: If there is a known allergy to alitretinoin or any other component in Hanzema.
- Liver or kidney disease: Patients with severe liver or kidney conditions should avoid Hanzema.
- High cholesterol: Those with uncontrolled high cholesterol may be at risk of adverse effects.
- Hypervitaminosis A: Patients with a history of too much Vitamin A should not use Hanzema.
- Tetracycline antibiotics: Concurrent use may increase the risk for brain pressure.
Cautions
- Before starting treatment with Hanzema, be sure to inform your healthcare provider about the following:
- Any medical conditions you currently have
- Any allergies
- All medications you are currently taking
- Whether you are pregnant or breastfeeding
- Hanzema is extremely harmful in pregnancy and is strictly contraindicated. Women of childbearing potential must use two effective forms of contraception simultaneously, starting one month before treatment, throughout treatment, and for one month after stopping Hanzema. This includes undergoing regular pregnancy testing and committing to the Hanzema Pregnancy Prevention Program.
- There's a risk of benign intracranial hypertension, particularly when used with tetracyclines. Symptoms like headache, nausea, vomiting, visual disturbances, and papilloedema warrant immediate discontinuation of Hanzema.
- Comprehensive contraception advice is critical. Effective contraception methods include tubal sterilization, partner’s vasectomy, intrauterine devices (IUDs), and hormonal contraceptives. Complementary methods like condoms or diaphragms should also be used.
- Patients should not donate blood during and for one month after treatment to avoid risking a pregnant transfusion recipient’s exposure to Hanzema.
- Treatment with Hanzema can increase cholesterol and triglyceride levels, which may necessitate discontinuation if levels become uncontrollable or if symptoms like pancreatitis develop.
- Treatment may affect thyroid hormone levels, often showing as reduced thyroid stimulating hormone (TSH) and T4 levels.
- Hanzema can worsen or trigger inflammatory bowel disease. Severe gastrointestinal symptoms should lead to immediate discontinuation.
- Liver enzymes should be regularly monitored, and Hanzema discontinued if significant liver enzyme elevations persist.
- Hanzema may affect bones, potentially leading to early bone closure in young people or bone growth issues.
- Patients should be screened for depression or psychiatric symptoms before starting and during treatment with Hanzema, as it can cause depression, mood disturbances, or even suicidal thoughts.
- Patients should avoid excessive UV light exposure and use moisturizing skin care to manage dryness, which is a common side effect.
- Dry eyes and other vision-related issues can occur, requiring ointment or other treatments to manage discomfort. Visual difficulties should lead to immediate ophthalmological consultation.
- Contraception must continue for at least one month post-treatment to ensure no risk of pregnancy with residual medication effects.
Side Effects
Alitretinoin side effects may include headaches, increased levels of blood fats such as cholesterol, or changes in blood cell counts. Thyroid problems leading to decreased hormone levels, dry and irritated eyes, muscle and joint pain, and skin issues like dryness or itching are also common. Some patients may notice changes in liver enzymes which are usually detected through blood tests.
Serious side effects include mental health changes such as depression or mood swings, which in rare cases, could lead to thoughts of self-harm or suicide. Vision issues like blurred or distorted vision could occur, demanding caution with driving or operating machinery. Severe allergic reactions may cause swelling that affects breathing or intense skin rashes, requiring immediate medical attention. In addition, sudden severe abdominal pain or symptoms that suggest a serious allergic reaction should prompt an urgent visit with a healthcare provider.
References
Hanzema (Alitretinoin) Product Monograph. Princeton, NJ: Dr. Reddy’s Laboratories, Inc.; 2019.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 13802
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