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Tharolax® (hydroxyurea capsules, USP)

500 mg per capsule

hydroxyurea capsules, is a chemotherapy drug

What is hydroxyurea (Tharolax)?

THAROLAX (hydroxyurea capsules, USP) is a prescription medicine that is used to reduce the frequency of painful crises and reduce the need for blood transfusions in adults with sickle cell anemia. How THAROLAX works is not certain but it may work by reducing the number of white blood cells and/or increasing red blood cells that carry fetal hemoglobin (HbF). Fetal hemoglobin may prevent sickling.

Who should not take THAROLAX capsules?

Do not take THAROLAX capsules if you are allergic to any of the ingredients. Besides the active ingredient hydroxyurea, THAROLAX capsules contain the following inactive ingredients: citric acid, gelatin, lactose, magnesium stearate, sodium phosphate, titanium dioxide, and capsule colorants. Tell your doctor if you think you have ever had an allergic reaction.

If you get pregnant, THAROLAX may harm or cause death to your unborn child. You should not become pregnant while taking THAROLAX. Make sure you use a contraceptive method. Tell your doctor if you become pregnant or plan to become pregnant while taking THAROLAX.

How do I take THAROLAX capsules?

Always follow your doctor’s instructions carefully when taking THAROLAX capsules or any prescription medication. The usual dose of THAROLAX may range from as few as one to several capsules per day. THAROLAX is usually taken once a day. You should try to take it at the same time each day. Your doctor will determine the proper starting dose of THAROLAX for you based on your weight and blood count. The dose will then be increased slowly to your maximum tolerated dose (maximum dose that does NOT produce severely low blood counts). Your doctor should measure your blood counts every two weeks after you begin treatment with THAROLAX. Depending on the results, your dosage may be adjusted or the drug may be stopped for a while.

If you accidentally take an overdose of THAROLAX capsules, seek medical attention immediately. Contact your doctor, local Poison Control Center, or emergency room.

How do I handle THAROLAX capsules safely?

THAROLAX is a medication that must be handled with care. People who are not taking THAROLAX should not be exposed to it. To decrease the risk of exposure, wear disposable gloves when handling THAROLAX or bottles containing THAROLAX. Anyone handling THAROLAX should wash their hands before and after contact with the bottle or capsules. If the powder from the capsule is spilled, it should be wiped up immediately with a damp disposable towel and discarded in a closed container, such as a plastic bag. THAROLAX should be kept out of the reach of children and pets. Contact your doctor or pharmacist for instructions on how to dispose of outdated capsules.

What if I miss a dose of THAROLAX capsules?

Try not to miss your dose of THAROLAX, but if you do, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses during the same day. If you miss more than one dose, call your doctor for instructions.

What should I avoid while taking THAROLAX capsules?

Some other medications can increase your risk of experiencing serious side effects from THAROLAX. While you are taking THAROLAX capsules, you should inform your doctor of all prescription and over-the-counter medicines that you are taking.

In nursing mothers, THAROLAX is present in breast milk. Because of the potential for side effects in the newborn, you should discontinue nursing your baby while taking THAROLAX.

What are the possible side effects of THAROLAX capsules?

As with other medicines, THAROLAX may cause unwanted effects, although it is not always possible to tell whether such effects are caused by THAROLAX, another medication you may be taking, or your sickle cell anemia. Any side effects or unusual symptoms that you experience should be reported to your doctor, particularly if they persist or are troublesome.

The most serious side effects of THAROLAX involve the blood, and may include severely low white blood cell counts (leukopenia, neutropenia), which can decrease your resistance to infections, severely low red blood cell counts (anemia), or severely low platelet counts (thrombocytopenia), which can cause bleeding. Almost all patients who received THAROLAX in clinical studies needed to have their medication stopped for a time to allow their low blood counts to return to acceptable levels.

The side effects reported most often by adults with sickle cell anemia participating in studies of THAROLAX included hair loss, skin rash, fever, stomach and/or bowel disturbances, weight gain, bleeding, virus infection, and discolored nails (melanonychia), but these were equally common in people getting a placebo (sugar pill).

Skin cancer and leukemia, which can be fatal, have been reported in patients receiving long-term hydroxyurea for conditions other than sickle cell anemia. In laboratory tests, THAROLAX causes changes in chromosomes and DNA (genetic material) that strongly suggest it can cause cancer in people, especially if it is taken for a long time.

Skin ulcers have been seen in patients taking THAROLAX therapy. Contact your doctor if skin ulcers develop while you are taking THAROLAX.

Are regular blood counts necessary while taking THAROLAX capsules?

Yes. Your doctor should measure your blood counts every two weeks while you are taking THAROLAX. Your THAROLAX dose will require adjustment based on these regular blood counts. Serious problems can occur if the THAROLAX dose is not adjusted on time.

What else should I know about THAROLAX capsules?

If you have kidney or liver disease, close monitoring of your blood count, kidney and liver function will be required. If you have kidney disease, your dose of THAROLAX may be started at a lower level and increased gradually.

Because it may not be possible to detect a deficiency of folic acid in patients taking THAROLAX, your doctor may prescribe a folic acid supplement for you.

What else should I do to control my sickle cell crises?

Because painful crises can be brought on by factors such as infection, dehydration, worsening anemia, emotional stress, extreme temperature exposure, or ingestion of substances such as alcohol or other recreational drugs, you should be aware of the following general guidelines that will help keep you pain-free:

  • Seek immediate medical attention when a fever develops or signs of infection appear.
  • Avoid smoking and drinking more than 1 to 2 alcoholic beverages a day.
  • Drink 8 to 10 glasses of water or other fluid each day.
  • Avoid any types of physical exertion that seem to bring on painful crises or other discomfort.
  • Avoid extreme temperature changes and dress appropriately in hot and cold weather.

What should I know if I am HIV-positive?

Because of serious, life-threatening side effects associated with THAROLAX used in combination with certain medications for HIV, your doctor should closely monitor your pancreas and liver function with frequent physical examinations and laboratory blood tests. The combination of THAROLAX, stavudine and didanosine should be avoided. Some studies have shown a decrease in the number of CD4 (T-cells) for HIV-positive patients taking THAROLAX. Although THAROLAX is approved by the U.S. Food and Drug Administration for treating sickle cell anemia, it is not approved for treating HIV infection.

This medicine was prescribed for your particular condition. Do not use THAROLAX capsules for another condition or give it to others. This summary does not include everything there is to know about THAROLAX capsules. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. If you have questions or concerns, or want more information about THAROLAX capsules, your physician and pharmacist have the complete prescribing information upon which this guide is based. You may want to read it and discuss it with your doctor. Remember, no written summary can replace careful discussion with your doctor.

This Patient Information has been approved by the U.S. Food and Drug Administration.


THAROLAX ® capsules is made in India by:

Taj Pharmaceuticals Limited.

THAROLAX is a trademark of a Taj Pharma Company

Important Safety Information

Treatment of patients with THAROLAX may be complicated by severe, sometimes lifethreatening, adverse effects. THAROLAX should be administered under the supervision of a physician experienced in the use of this medication for the treatment of sickle cell anemia.

Hydroxyurea is mutagenic and clastogenic, and causes cellular transformation to a tumorigenic phenotype. Hydroxyurea is thus unequivocally genotoxic and a presumed transspecies carcinogen which implies a carcinogenic risk to humans. In patients receiving long-term hydroxyurea for myeloproliferative disorders, such as polycythemia vera and thrombocythemia, secondary leukaemia’s have been reported. It is unknown whether this leukemogenic effect is secondary to hydroxyurea or is associated with the patient's underlying disease. The physician and patient must very carefully consider the potential benefits of THAROLAX relative to the undefined risk of developing secondary malignancies. Tharolax is used to treat chronic myeloid leukaemia or cervical cancer.

Your medical team will discuss with you the options for treating your cancer. They will take into account factors such as the type of cancer, where it is, which stage it is at and whether you have had treatment before. The results of blood tests and other investigations will also be considered. How well you feel and how you are likely to cope with treatment is also important.

Your cancer treatment will usually consist of a treatment session with Tharolax followed by a break of a number of days before the next treatment session with Tharolax. This cycle may be repeated many times as part of your cancer treatment. Tharolax works by damaging cancer cells in the body. Tharolax also affects healthy cells and treatment with Tharolax may damage your immune system. Your medical team may arrange for you to have some blood tests to check how well your immune system is working. Do not share your medicine with other people. It may not be suitable for them and may harm them. The pharmacy label on your medicine tells you how much medicine you should take. It also tells you how often you should take your medicine. This is the dose that you and your prescriber have agreed you should take. You should not change the dose of your medicine unless you are told to do so by your prescriber. If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber.

Patient Information

Full Prescribing Information