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About RUXOLITINIB

RUXOLITINIB belongs to the group of medicines called kinase inhibitors indicated in the treatment of myelofibrosis (cancer of bone marrow), polycythaemia vera (cancer of the blood), and graft-versus-host disease (GVHD, a complication of hematopoietic stem-cell transplant).
 
RUXOLITINIB contains Ruxolitinib, which works by blocking the signals that cause cancer cells to multiply. Thereby, it helps treat myelofibrosis and polycythaemia vera. RUXOLITINIB helps treat graft-versus-host disease by blocking the signals of the cells that cause GVHD.
 
In some cases, RUXOLITINIB may cause side effects such as dizziness, headache, weight gain, fever, and constipation. Most of these side effects may not require medical attention and resolve over time. Talk with your doctor if any of the side effects persist or worsen.
 
Let the doctor know if you are allergic to any components in RUXOLITINIB. This medicine is not recommended during pregnancy and breastfeeding. Keep your doctor informed about your health condition and medications to rule out any side effects/interactions.

Uses of RUXOLITINIB

Myelofibrosis, polycythaemia vera (PV), and graft-versus-host disease (GVHD).

Medicinal Benefits

RUXOLITINIB belongs to the group of medicines called kinase inhibitors indicated in the treatment of myelofibrosis and polycythaemia vera in adults. It is also used to treat graft-versus-host disease in adults and children above 12 years of age. RUXOLITINIB contains Ruxolitinib, which works by blocking the action of Janus-associated kinase enzymes, reduces the size of the spleen in patients with myelofibrosis and relieves symptoms like fever, bone pain, night sweats, and weight loss. RUXOLITINIB selectively blocks enzymes called Janus Associated Kinases (JAK1 and JAK2); this helps relieve the symptoms, reduce spleen size and the volume of red blood cells produced in patients with polycythaemia vera, thus potentially reducing the risk of serious blood or vascular complications. RUXOLITINIB reduces signs and symptoms of the acute and chronic forms of graft-versus-host disease, leading to disease improvement and survival of the transplanted cells. 

Directions for Use

Take RUXOLITINIB exactly as advised by the doctor. Swallow the medicine as a whole with water; do not crush or chew it.

Storage

Store in a cool and dry place away from sunlight

Side Effects of RUXOLITINIB

  • Dizziness
  • Headache
  • Weight gain
  • Fever
  • Cough
  • Urinary tract infections
  • Constipation
  • Hypertriglyceridaemia (high cholesterol levels)

In-Depth Precautions and Warning

Drug Warnings

Do not take RUXOLITINIB if you are allergic to any of its components or if you are pregnant/breastfeeding. Inform the doctor if you have/had infections, tuberculosis, hepatitis B, kidney or liver problems, skin cancer, HIV or AIDS, anaemia, blood clots, heart attack or stroke, shingles, heart problems, high cholesterol, low blood count, if you smoke or if you are on dialysis. Seek medical attention if you experience symptoms of blood disorder (unexpected bleeding/bruising, shortness of breath, frequent infections, unusual tiredness or pale skin), infections (fever and chills), tuberculosis (chronic cough with blood-tinged sputum, night sweats, fever, and weight loss), serious brain infection (confusion or difficulty thinking, difficulty walking or loss of balance, difficulty speaking, weakness, blurred vision or loss of vision), shingles (painful skin rash with blisters), or skin cancer (any changes in skin). Let the doctor know if you are taking any other medicines, including supplements or herbal products.

Drug Interactions

Drug-Drug Interactions: Inform the doctor if you are taking anti-fungal (ketoconazole, itraconazole, posaconazole, fluconazole, voriconazole), antibiotics (clarithromycin, telithromycin, ciprofloxacin, erythromycin), anti-viral (amprenavir, atazanavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir), medicines to treat hepatitis C (boceprevir, telaprevir), anti-depressant (nefazodone), antacid (cimetidine), anti-epileptic (phenytoin, carbamazepine, phenobarbital), anti-TB (rifabutin, rifampicin), or herbal supplement (St. John’s wort).

Drug-Food Interactions: Grapefruit juice may increase the blood levels of Ruxolitinib. Therefore, avoid consuming grapefruit or its juice during treatment with RUXOLITINIB unless advised by the doctor.

Drug-Disease Interactions: Inform the doctor if you have heart problems, thrombosis (blood clots), hepatitis B infection, tuberculosis, infections, high lipid levels, lung problems, low blood count or cancer.

Drug-Drug Interactions Checker List:

  • KETOCONAZOLE
  • ITRACONAZOLE
  • POSACONAZOLE
  • FLUCONAZOLE
  • VORICONAZOLE
  • CLARITHROMYCIN
  • TELITHROMYCIN
  • CIPROFLOXACIN
  • ERYTHROMYCIN
  • AMPRENAVIR
  • ATAZANAVIR
  • INDINAVIR
  • LOPINAVIR+RITONAVIR
  • NELFINAVIR
  • RITONAVIR
  • SAQUINAVIR
  • BOCEPREVIR
  • TELAPREVIR
  • NEFAZODONE
  • CIMETIDINE
  • PHENYTOIN
  • CARBAMAZEPINE
  • PHENOBARBITAL
  • RIFABUTIN
  • RIFAMPICIN
  • ST JOHN'S WORT
  • Safety Advice

    • Safety Warning

      Alcohol

      consult your doctor

      It is not known if alcohol interacts with RUXOLITINIB. Please consult the doctor.

    • Safety Warning

      Pregnancy

      unsafe

      Ruxolitinib belongs to pregnancy category C. Do not take RUXOLITINIB if you are pregnant. Consult the doctor if you are pregnant, planning for pregnancy or if you think you are pregnant.

    • Safety Warning

      Breast Feeding

      unsafe

      It is not known if Ruxolitinib passes into breast milk. Avoid breastfeeding while on treatment with RUXOLITINIB and for 2 weeks after the last dose.

    • Safety Warning

      Driving

      caution

      If you experience dizziness after taking RUXOLITINIB, avoid driving or operating heavy machinery.

    • Safety Warning

      Liver

      caution

      Dose adjustment may be needed in patients with hepatic impairment. If you have a history of liver problems, inform the doctor before taking RUXOLITINIB.

    • Safety Warning

      Kidney

      caution

      Dose adjustment may be needed in patients with moderate or severe renal impairment. It may not be recommended for patients with end-stage renal disease not requiring dialysis. If you have a history of kidney problems, inform the doctor before taking RUXOLITINIB.

    • Safety Warning

      Children

      unsafe

      RUXOLITINIB is not intended for use by children below 18 years for the treatment of myelofibrosis or polycythaemia vera. For graft-versus-host disease, this medicine is not recommended for children below 12 years as the safety and effectiveness have not been established.

    Habit Forming

    No

    Diet & Lifestyle Advise

    • Eat a healthy diet and exercise regularly to maintain proper weight.
    • Avoid smoking and alcohol consumption.
    • Include vegetables, whole grains and fruits in your diet.
    • Get optimal sleep; rest well.
    • Limit fast food, processed meat, salty snacks, highly processed foods and beverages.

    Special Advise

    Your doctor may advise regular blood tests prior to the start of the treatment and during treatment.

    Patients Concern

    Disease/Condition Glossary

    Myelofibrosis: Myelofibrosis is a disorder of the bone marrow in which the marrow is replaced by scar tissue. The abnormal marrow can no longer produce enough normal blood cells, and as a result, the spleen becomes significantly enlarged. Enlargement of the spleen is one of the characteristics of myelofibrosis. Symptoms include abdominal fullness, bone pain, fatigue, easy bleeding/bruising, pale skin, and weight loss.

    Polycythaemia vera (PV): Polycythaemia vera is a disorder of the bone marrow in which the marrow produces too many red blood cells. The blood becomes thicker as a result of the increased red blood cells. Symptoms of PV are headache, confusion, dizziness, itching, night sweats, and extreme tiredness.

    Graft-versus-host disease (GVHD): Graft-versus-host disease is a complication that occurs after transplantation when specific cells (T cells) in the donor’s graft (e.g. bone marrow) do not recognise the host cells/organs and attack them. Symptoms may include abdominal pain, mouth ulcers, and rash.

    FAQs

    How does RUXOLITINIB work?

    RUXOLITINIB helps treat myelofibrosis and polycythaemia vera by blocking the signals that cause cancer cells to multiply. It helps treat graft-versus-host disease by blocking the signals of the cells that cause GVHD.

    Does RUXOLITINIB cause infections?

    RUXOLITINIB may decrease your ability to fight infections and increase the risk of serious infection. Consult the doctor if you develop signs of infection such as fever, chills, sweats, sore throat, cough, sore, or frequent/urgent/painful urination.

    Can I take other medicines during treatment with RUXOLITINIB?

    Do not start a new medicine, including prescription medicines, non-prescription medicines and herbal or supplement medicines, whilst on treatment with RUXOLITINIB without consulting your doctor.

    Does RUXOLITINIB increase the risk of tuberculosis?

    RUXOLITINIB may increase the risk of developing tuberculosis (TB), particularly if you are already infected with TB but do not have any symptoms. Inform the doctor if you have had TB or if you experience symptoms of TB like cough, cough with blood or mucus, weight loss, weakness or tiredness, loss of appetite, chills, fever, or night sweats.

    Available Medicines for

    RUXOLITINIB