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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.
Siklos® is the first and only FDA-approved prescription medicine that is used to reduce the frequency of painful crises and reduce the need for blood transfusions in children, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crises. It is not known if Siklos® is safe and effective in children less than 2 years of age.
SIKLOS can harm your unborn baby. For females taking SIKLOS who can become pregnant: You should talk with your healthcare provider about the risks of SIKLOS to your unborn baby. You should use effective birth control during treatment with SIKLOS and for at least 6 months after treatment with SIKLOS. Your healthcare provider will perform a pregnancy test before you start treatment with SIKLOS. Tell your healthcare provider right away if you become pregnant or think you may be pregnant. For males taking SIKLOS: SIKLOS can affect your sperm. If you have a female sexual partner who can become pregnant, you should use effective birth control during treatment with SIKLOS and for at least 6 months after treatment. SIKLOS may cause fertility problems in males. Talk to your healthcare provider if this is a concern for you. WHO SHOULD NOT TAKE SIKLOS?
SIKLOS may cause serious side effects, including: See “What is the most important information I should know about SIKLOS?” Skin ulcers, including leg ulcers, and death of skin tissue (gangrene) have happened in people who take SIKLOS. This has happened most often in people who receive interferon therapy or have a history of interferon therapy. Your healthcare provider will decrease your dose or stop treatment with SIKLOS if you develop any skin ulcers. Enlarged red blood cells (macrocytosis). Macrocytosis is common in people who take SIKLOS and can make it difficult to detect a decrease of folic acid. Your healthcare provider may prescribe a folic acid supplement for you. The most common side effects of SIKLOS include: infections, headache, fever, skin problems (e.g., skin reactions, dry skin, changes in skin and nail color), stomach and intestine (gastrointestinal) problems (e.g. nausea and constipation), decrease in vitamin D, and weight gain. These are not all the possible side effects of SIKLOS.