1.What Pemitini is and what it is used for 

 Pemitini contains the active substance pemigatinib, which belongs to a group of cancer medicines called tyrosine kinase  inhibitors. It blocks the action of proteins in the cell called fibroblast growth factor receptor types 1, 2 and 3 (FGFR1, FGFR2, and  FGFR3) that help regulate cell growth. Cancer cells may have an abnormal form of this protein. By blocking FGFR, pemigatinib  can prevent the growth of such cancer cells. 

Pemitini is used: 

 • to treat adults with bile duct cancer (also known as cholangiocarcinoma) whose cancer cells have an abnormal form of the  FGFR2 protein, and  

• when the cancer has spread to other parts of the body or cannot be removed by surgery, and  

• when treatment with other medicines is no longer working.

2.How to take Pemitini

  Pemitini treatment should be started by a doctor who is experienced in the diagnosis and treatment of bile duct cancer. Always  take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. 

 The recommended dose is  

3 tablet of Pemitini 4.5 mg taken once daily for 14 days, followed by 7 days without taking Pemitini.Treatment is continued with the same pattern of 14 days of Pemitini once daily, followed by 7 days off therapy. Do not take  Pemitini during the 7 days off therapy. Your doctor will adjust the dose or stop treatment if needed.  

Method of use  

Swallow the tablet whole with one glass of water at the same time every day. Pemitini may be taken with food or between  meals.  Do not crush, chew, split or dissolve the tablets.

  Duration of use 

 Take Pemitini for as long as it is prescribed by the doctor. 

 If you take more Pemitini than you should

Tell your doctor if you have taken more Pemitini than you should have. 

 If you forget to take Pemitini  

If you miss a dose of Pemitini by 4 hours or more, or if you vomit after taking Pemitini, do not take another Pemitini tablet to  make up for the missed dose. Take your next dose of Pemitini at the scheduled time.  

If you stop taking Pemitini 

 Do not stop taking Pemitini without discussing it with your doctor, as this could reduce the success of therapy.  If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.Possible side effects 

 Like all medicines, this medicine can cause side effects, although not everybody gets them.  Tell your doctor immediately if you have any of the serious side effects below. These side effects may occur with the following  frequency: 

 Very common (may affect more than 1 in 10 people): 

 • low sodium in blood; symptoms include decreased ability to think, headache, nausea, poor balance, confusion, seizures, coma 

• blood tests showing increase of creatinine, which can suggest kidney problems; usually raised creatinine does not cause  symptoms, but symptoms of kidney problems may include nausea and changes in urination 

Other side effects may occur with the following frequencies:  

Very common (may affect more than 1 in 10 people) 

 • high or low phosphate levels seen in blood tests 

 • taste disturbance 

 • dry eye 

 • nausea  

• inflammation of the inner lining of the mouth  

• diarrhoea 

 • constipation  

• dry mouth 

 • skin reactions with redness, swelling and pain on palms of the hands and soles of the feet, called hand-foot syndrome 

 • nail toxicity, including nails separating from the nail bed, nail pain, nail bleeding, breaking of the nails, colour or texture changes  in your nails, infected skin around the nail  

• hair loss 

 • dry skin 

 • joint pain 

 • fatigue

  Common (may affect up to 1 in 10 people) 

 • fluid build-up under the retina (the light-sensitive layer at the back of the eye) 

 • inflammation of the cornea (the clear outer layer of the eye) 

 • reduced vision 

 • eyelash changes including abnormally long eyelashes, ingrown eyelashes 

 • abnormal hair growth

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not  listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.