Golimumab - Subcutaneous

Golimumab is used to treat various inflammatory diseases such as:

• moderate to severe ulcerative colitis (inflammation of the large intestines and rectum)
• ankylosing spondylitis (inflammation in the joints of your spine)
• severe non-radiographic axial spondyloarthritis (a rare type of joint inflammation in the spine)

This medicine may also be used on its own or together with other medicines to treat rheumatoid arthritis (inflammation in joints of fingers, wrist, feet, and ankles) and psoriatic arthritis (joint pain and inflammation that affects individuals with psoriasis).

Golimumab may be used to treat other conditions as decided by your doctor.

Golimumab is to be injected subcutaneously (into the fatty layer under the skin, usually in the thigh, upper arm, or abdomen area).

Your doctor or nurse will administer the injection for you. If you or your caregiver had been given the proper training on the preparation and injection techniques of this medicine, you or your caregiver may do the administration.

Use Golimumab exactly as directed by your doctor or according to the instructions on the label. Do not administer more or less than instructed by your doctor.

Remember to rotate the injection sites. Do not inject into the same area all the time. New injection sites should be at least 1.5 inches away from the previous injection site. Do not inject near the navel (belly button), and into areas where the skin is tender, bruised, red, hard, scarred, or with stretch marks.

Golimumab is available as a pre-filled pen or syringe. Make sure you know how to use the specific device you have been given. If you have problems or do not understand the instructions, ask your doctor or pharmacist.

The dose of this medicine will be decided by your doctor. Your doctor will advise you on the course of treatment depending on the type and severity of your condition and your response to the medication.

Golimumab must be administered regularly for it to be effective. Continue using this medicine even when you feel better. Do not stop using it unless instructed by the doctor.

Ensure that you keep all appointments with your doctor so that you do not miss any doses. Your doctor also needs to regularly monitor your response to Golimumab.

If you miss an appointment or miss an injection, alert your doctor or nurse. A replacement appointment or injection should be given as soon as possible.

If you or a caregiver had been trained to administer this medicine and missed a dose that is less than 2 weeks late, inject the missed dose as soon as you remember and return to your normal dosing schedule.

If it is more than 2 weeks late, inject the missed dose and start a new dosing schedule from this date of injection.

DO NOT double a dose under any circumstances.

Inform your doctor or pharmacist immediately if you forgot to administer your dose.

Do not use Golimumab if you ever had an allergic reaction (e.g. rashes, breathlessness, swollen eyes) to this medicine.

Alert your doctor if you have the following conditions:

• moderate to severe heart failure (weakness and inability of the heart to pump blood)
• active TB (lung infection known as tuberculosis) or other severe infections

as Golimumab may not be suitable for you.

Inform your doctor if you have the following conditions:

• history of serious infections
• long-term or recurrent infections
• underlying conditions that make you prone to infections
• mild heart failure (weakness and inability of the heart to pump blood)
• current or history of cancer
• current or history of blood disorders
• demyelinating disorders (condition that leads to damage in the protective covering of nerve fibres in the brain or spinal cord)

It is important that you do not get pregnant while being treated with this medicine. You may wish to discuss birth control methods with your doctor or pharmacist. Avoid pregnancy for at least 6 months after you stop using this medicine.

Do not breastfeed while you are being treated with Golimumab and for at least 6 months after the last dose.

Be sure to check with your doctor or pharmacist before giving this medicine to a child or the elderly. Children or elderly people may be more sensitive to the side effects.

If you are going to have an operation, including minor surgery and dental work, inform your doctor or dentist that you are using this medicine.

Inform your doctor if you have resided in or travelled to areas with endemic cases of TB or fungal infections.

Why is it important to keep my appointments with the doctor?

Keep your appointments with your doctor. Your doctor needs to monitor your condition and check your response to the medication regularly.

• Screening tests for TB and hepatitis B or C may be done before treatment to know if this medicine is suited for you to use.
• Routine tests (e.g. complete blood count, skin examination) may be done while you are being treated with this medicine. Your doctor will advise you about how often you need to have these tests.
• Regular monitoring of signs and symptoms of infection, heart failure, allergic reactions, lupus (autoimmune disease that causes inflammation of certain organs in the body), and cancer may also be needed.

Golimumab may cause any of the following side effects: dizziness, headache, nausea, stomach pain, indigestion, cough, runny nose, chest discomfort, hair loss, and swelling, pain, redness or itching at the injection site.

Some side effects may need immediate medical help. Alert your doctor quickly if you experience any of the following:

• signs and symptoms of allergic reaction e.g. rashes, breathlessness, swelling of the face, eyes, or mouth
• signs and symptoms of heart problems e.g. abnormal heartbeat, shortness of breath, sudden weight gain, swelling in the arms or legs
• signs and symptoms of lupus e.g. rash on the cheeks or other parts of the body, easily sunburned skin, chest pain or discomfort, shortness of breath, joint or muscle pain
• fever, chills, very bad sore throat, ear or sinus pain, persistent cough, night sweats, excessive phlegm production or a change in the colour of the phlegm, pain when passing urine, mouth sores
• unexplained or unusual bleeding or bruising, paleness, small or purple spots under the skin
• yellowing of the skin or eyes, abdominal pain, dark coloured urine, unusual tiredness
• changes in vision, weakness in the arms or legs, numbness or tingling in any part of your body

Inform your doctor if any of these side effects do not go away or are severe, or if you experience other side effects.

Inform your doctor or pharmacist if you are taking any of these medicines:

• other medicines for rheumatoid arthritis e.g. abatacept, etanercept, anakinra
• rituximab (medicine for cancer)

This list does not include all medicines that may interact with Golimumab.

Avoid vaccinations with live vaccines during treatment with this medicine. Alert your doctor if you have been recently vaccinated or if you are planning to get vaccinated.

Always notify your doctor and pharmacist if you are taking any other medicines, including herbal tonics such as traditional Chinese medicines, supplements, and medicines that you buy without a prescription.

Avoid alcohol.

Store in the refrigerator, between 2-8°C. Do not allow Golimumab to freeze. If frozen, this medicine will become ineffective and should not be used.

Golimumab may be stored at room temperature not exceeding 25°C for up to 30 days. Throw away the prefilled syringe or pen if not used within 30 days. Do not return to the refrigerator once stored at room temperature. Mark the date that you took this medicine out of the refrigerator so that you know when to discard it.

Do not shake. Protect from light.

If you notice that the injection has changed colour or has become cloudy, do not use it. Throw it away and use a new injection.

Medicines must not be used past the expiry date.