Description
Ustekinumab-ttwe injection is used to treat moderate to severe plaque psoriasis in patients who may benefit from receiving phototherapy (ultraviolet light treatment) or other treatment. This medicine is also used to treat active psoriatic arthritis.
Ustekinumab-ttwe injection is also used to treat moderate to severe active Crohn's disease and ulcerative colitis.
This medicine is available only with your doctor's prescription.
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of ustekinumab-ttwe injection in children younger than 6 years of age to treat moderate to severe plaque psoriasis and psoriatic arthritis and in children to treat Crohn's disease and ulcerative colitis. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ustekinumab-ttwe injection in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abatacept
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Anifrolumab-fnia
- Bacillus of Calmette and Guerin Vaccine, Live
- Baricitinib
- Cholera Vaccine, Live
- Cyclosporine
- Dengue Tetravalent Vaccine, Live
- Ebola Zaire Vaccine, Live
- Infliximab
- Influenza Virus Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Poliovirus Vaccine, Live
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine, Live Non-Replicating
- Smallpox Vaccine
- Typhoid Vaccine, Live
- Varicella Virus Vaccine, Live
- Warfarin
- Yellow Fever Vaccine
- Zoster Vaccine, Live
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Cancer, or history of—Use with caution. May increase risk for cancer.
- Infection (eg, bacterial, fungal, viral)—Use is not recommended in patients with an active infection. Caution should be used if you have a chronic infection or history of a recurring infection.
- Tuberculosis infection, inactive—Should be treated first before starting therapy with this medicine.
Proper Use
Vial: A nurse or other trained health professional will give you or your child this medicine in a medical facility. It is given through an IV that is placed in one of your veins.
Prefilled syringe: You may also be taught how to give this medicine at home. It is usually given as a shot under the skin of your buttocks, stomach, thigh, or upper arm.
This medicine comes with a Medication Guide and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.
You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into skin areas that are tender, red, bruised, or hard.
This medicine is available in 2 forms: a prefilled syringe or a vial (glass container).
To use the prefilled syringe:
- Wash your hands with soap and water before and after using this medicine.
- Allow 30 minutes for the syringe to warm up to room temperature. Do not warm using other heat sources (eg, hot water or microwave).
- Check the liquid in the syringe. It should be clear and colorless to light yellow. Do not use if it is frozen, discolored, cloudy, or has particles in it. Do not use the syringe if it is damaged or has been dropped. Do not shake.
- Remove the needle cover. Do not touch the plunger or plunger head while removing the needle cover.
- Hold the body of the syringe with one hand, and pull the needle cover straight off. Do not pull back on the plunger at any time.
- Gently pinch the skin. Use a quick, dart-like motion to insert the needle into the pinched skin at about a 45 degree angle.
- Push in the plunger until the plunger head is completely between the needle guard wings.
- Slowly take your thumb off the plunger head. This will let the empty syringe move up until the entire needle is covered by the needle guard.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injection dosage form (prefilled syringe):
- For Crohn's disease and ulcerative colitis:
- Adults—At first, this medicine is injected into your vein through an IV as a single dose. After 8 weeks, a maintenance dose of 90 milligrams (mg) is injected under your skin as a single dose, then every 8 weeks after.
- Children—Use and dose must be determined by your doctor.
- For plaque psoriasis:
- Adults—Dose is based on body weight and must be determined by your doctor:
- Weighing more than 100 kilograms (kg)—At first, 90 milligrams (mg) injected under your skin as a single dose, and then one dose (90 mg) after 4 weeks, followed by 90 mg every 12 weeks.
- Weighing 100 kg or less—At first, 45 mg injected under your skin as a single dose, and then one dose (45 mg) after 4 weeks, followed by 45 mg every 12 weeks.
- Children 6 years of age and older—Dose is based on body weight and must be determined by your doctor:
- Weighing more than 100 kilograms (kg)—90 milligrams (mg) at Weeks 0 and 4, then every 12 weeks after.
- Weighing 60 kg to 100 kg—45 mg at Weeks 0 and 4, then every 12 weeks after.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- Adults—Dose is based on body weight and must be determined by your doctor:
- For psoriatic arthritis:
- Adults—Dose is based on body weight and must be determined by your doctor:
- Weighing more than 100 kilograms (kg) who also have plaque psoriasis—At first, 90 milligrams (mg) injected under your skin as a single dose, and then one dose (90 mg) after 4 weeks, followed by 90 mg every 12 weeks.
- Weighing less than 100 kg—At first, 45 mg injected under your skin as a single dose, and then one dose (45 mg) after 4 weeks, followed by 45 mg every 12 weeks.
- Children 6 years of age and older—Dose is based on body weight and must be determined by your doctor:
- Weighing more than 100 kilograms (kg) who also have plaque psoriasis—90 milligrams (mg) at Weeks 0 and 4, then every 12 weeks after.
- Weighing 60 kg to 100 kg—45 mg at Weeks 0 and 4, then every 12 weeks after.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- Adults—Dose is based on body weight and must be determined by your doctor:
- For Crohn's disease and ulcerative colitis:
Missed Dose
This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store in the refrigerator. Do not freeze.
If needed, you may store the prefilled syringe at room temperature for up to 60 days. You may put it back in the refrigerator 1 time only for 3 days, either during or at the end of the 60-day period. Throw away unused medicine after 60 days of room temperature storage and if you did not return it in the refrigerator, or if it has been returned in the refrigerator and is not used within 3 days.
Do not reuse syringes and needles. Put used syringes and needles in a puncture-resistant disposable container, or dispose of them as directed by your doctor.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause serious infections (eg, bacterial, fungal, viral). Check with your doctor right away if you have chest tightness, stomach pain, fever, itching, pain or redness of the skin, indigestion, nausea, vomiting, chills, confusion, dizziness, fast heartbeat, bone pain, diarrhea, loss of appetite, weakness, bleeding in the eye, blurred vision, trouble breathing, sneezing, or cough.
You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis test or been exposed to tuberculosis.
This medicine may increase your risk of getting some forms of cancer (eg, non-melanoma skin cancer). This is more likely to occur if you are over 60 years of age or if you are receiving PUVA therapy (psoralen and ultraviolet A treatment) or have received medicines that weaken the immune system (eg, steroids). Talk to your doctor about this risk if you have concerns.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.
Check with your doctor if you have headache, seizures, confusion, or blurred vision or other visual problems. These may be symptoms of a rare and serious condition called posterior reversible encephalopathy syndrome (PRES) or reversible posterior leukoencephalopathy syndrome (RPLS).
While you are being treated with ustekinumab-ttwe and after you stop treatment with it, do not have any immunizations (especially live vaccines) without your doctor's approval. Ustekinumab-ttwe may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, the other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also avoid persons who have recently taken oral polio vaccine. Do not get close to them or stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective mask that covers the nose and mouth. You should not receive BCG vaccine 1 year before and 1 year after receiving this medicine.
This medicine may cause non-infectious pneumonia (eg, interstitial pneumonia, eosinophilic pneumonia, cryptogenic organizing pneumonia). Check with your doctor right away if you have chest pain or tightness, cough, fever or chills, sneezing, sore throat, or trouble breathing.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Body aches or pain
- chills
- cough
- ear congestion
- fever
- headache
- loss of voice
- sneezing
- sore throat
- stuffy or runny nose
- trouble breathing
- unusual tiredness or weakness
Less common
- Bladder pain
- bloody or cloudy urine
- difficult, burning, or painful urination
- frequent urge to urinate
- itching of the genitals
- lower back or side pain
- persistent non-healing sore
- pink growth
- reddish patch or irritated area
- shiny bump
- thick, white vaginal discharge with mild or no odor
- white, yellow or waxy scar-like area
Rare
- Discouragement
- feeling sad or empty
- irritability
- lack of appetite
- loss of interest or pleasure
- trouble concentrating
- trouble sleeping
Incidence not known
- Agitation
- blisters on the skin
- bloating
- blurred vision
- chest pain or tightness
- cold flu-like symptoms
- coma
- confusion
- cough or hoarseness
- diarrhea
- difficulty swallowing
- dizziness
- drowsiness
- fainting
- fast heartbeat
- general feeling of illness
- hallucinations
- hives, itching, skin rash
- increase in bone pain
- indigestion
- itching, pain, redness, swelling, tenderness, warmth on the skin
- large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lightheadedness
- mood or mental changes
- muscle aches
- nausea
- night sweats
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- seizures
- severe cramping
- spots on your skin resembling a blister or pimple
- stiff neck or back
- stomach pain or tenderness
- vomiting
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Cough producing mucus
- difficulty in moving
- joint pain
- muscle cramps, pains, or stiffness
- pain or tenderness around the eyes and cheekbones
- swollen joints
Rare
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
