INDICATIONS
[COSENTYX® (secukinumab) is a prescription medicine used to treat people 6 years of age and older with moderate to severe plaque psoriasis (PsO) that involves large areas or many areas of the body, and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light alone or with systemic therapy).]
[COSENTYX® (secukinumab) is a prescription medicine used to treat people 2 years of age and older with active psoriatic arthritis (PsA).]
[COSENTYX® (secukinumab) is a prescription medicine used to treat adults with active ankylosing spondylitis (AS).]
[COSENTYX® (secukinumab) is a prescription medicine used to treat adults with active non‐ radiographic axial spondyloarthritis (nr-axSpA) and objective signs of inflammation.]
[COSENTYX® (secukinumab) is a prescription medicine used to treat people 4 years of age and older with active enthesitis-related arthritis (ERA).]
[COSENTYX® (secukinumab) is a prescription medicine used to treat adults with moderate to severe hidradenitis suppurativa (HS).]
INDICATIONS
COSENTYX® (secukinumab) is a prescription medicine used to treat:
· people 6 years of age and older with moderate to severe plaque psoriasis (PsO) that involves large areas or many areas of the body, and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light alone or with systemic therapy)
· people 2 years of age and older with active psoriatic arthritis (PsA)
· adults with active ankylosing spondylitis (AS)
· adults with active non-radiographic axial spondyloarthritis (nr-axSpA) and objective signs of inflammation
· people 4 years of age and older with active enthesitis-related arthritis (ERA)
· adults with moderate to severe hidradenitis suppurativa (HS)
IMPORTANT SAFETY INFORMATION
Do not use COSENTYX if you have had a severe allergic reaction to secukinumab or any of the other ingredients in COSENTYX. See the Medication Guide for a complete list of ingredients.
What is the most important information I should know about COSENTYX?
COSENTYX is a medicine that affects your immune system. COSENTYX may increase your risk of having serious side effects such as:
Infections
COSENTYX may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have died from these infections.
· Your doctor should check you for tuberculosis (TB) before starting treatment with COSENTYX.
· If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with COSENTYX and during treatment with COSENTYX.
· Your doctor should watch you closely for signs and symptoms of TB during treatment with COSENTYX. Do not use COSENTYX if you have an active TB infection.
Before starting COSENTYX, tell your doctor if you:
· are being treated for an infection
· have an infection that does not go away or that keeps coming back
· have TB or have been in close contact with someone with TB
· think you have an infection or have symptoms of an infection such as:
NOTE: The following format is an acceptable alternative to the bulleted version above; decision may be made at the brand team’s discretion.
· think you have an infection or have symptoms of an infection such as: fevers, sweats, or chills; muscle aches; cough; shortness of breath; blood in your phlegm; weight loss; warm, red, or painful skin or sores on your body; diarrhea or stomach pain; burning when you urinate or urinate more often than normal
After starting COSENTYX, call your doctor right away if you have any signs of infection listed [above]. Do not use COSENTYX if you have any signs of infection unless you are instructed to by your doctor. What are the possible side effects of COSENTYX?
COSENTYX may cause serious side effects, including: Serious allergic reactions
Serious allergic reactions can occur. Get emergency medical help right away if you get any of the following symptoms: feeling faint; swelling of your face, eyelids, lips, mouth, tongue, or throat; trouble breathing or throat tightness; chest tightness; skin rash or hives (red, itchy bumps).
If you have a severe allergic reaction, do not give another injection of COSENTYX.
Inflammatory bowel disease
New cases of inflammatory bowel disease or “flare-ups” can happen with COSENTYX, and can sometimes be serious. If you have inflammatory bowel disease (ulcerative colitis or Crohn’s disease), tell your doctor if you have worsening disease symptoms during treatment with COSENTYX or develop new symptoms of stomach pain or diarrhea. Severe skin reactions that look like eczema can happen during treatment with COSENTYX from days to months after your first dose and can sometimes lead to hospitalization. Your doctor may temporarily stop treatment with COSENTYX if you develop severe skin reactions. Tell your doctor if you have any of the following signs or symptoms: redness or rash; itching; small bumps or patches; your skin is dry or feels like leather; blisters on the hands or feet that ooze or become crusty or skin peeling.
The most common side effects of COSENTYX include: cold symptoms, diarrhea, and upper respiratory tract infections.
These are not all of the possible side effects of COSENTYX. Call your doctor for medical advice about side effects.
Before using COSENTYX, tell your doctor if you:
· have any of the conditions or symptoms listed [above] for infections.
· have inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
· are allergic to latex. The needle cap on the COSENTYX Sensoready® pen, and 150 mg/mL and 75 mg/0.5 mL prefilled syringes contains latex.
· have recently received or are scheduled to receive an immunization (vaccine). People who take COSENTYX should not receive live vaccines. Children should be brought up to date with all vaccines before starting COSENTYX.
· have any other medical conditions and all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.
· are pregnant or plan to become pregnant. It is not known if COSENTYX can harm your unborn baby. You and your doctor should decide if you will use COSENTYX.
· are breastfeeding or plan to breastfeed. It is not known if COSENTYX passes into your breast milk.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full Prescribing Information, including Medication Guide.
· fevers, sweats, or chills
· muscle aches
· cough
· shortness of breath
· blood in your phlegm
· weight loss
· warm, red, or painful skin or sores on your body
· diarrhea or stomach pain
· burning when you urinate or urinate more often than normal
IMPORTANT SAFETY INFORMATION
Do not use COSENTYX if you have had a severe allergic reaction to secukinumab or any of the other ingredients in COSENTYX. See the Medication Guide for a complete list of ingredients.
What is the most important information I should know about COSENTYX?
COSENTYX is a medicine that affects your immune system. COSENTYX may increase your risk of having serious side effects such as:
Infections
COSENTYX may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have died from these infections.
· Your doctor should check you for tuberculosis (TB) before starting treatment with COSENTYX.
· If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with COSENTYX and during treatment with COSENTYX.
· Your doctor should watch you closely for signs and symptoms of TB during treatment with COSENTYX. Do not use COSENTYX if you have an active TB infection.
Before starting COSENTYX, tell your doctor if you:
· are being treated for an infection
· have an infection that does not go away or that keeps coming back
· have TB or have been in close contact with someone with TB
· think you have an infection or have symptoms of an infection such as:
NOTE: The following format is an acceptable alternative to the bulleted version above; decision may be made at the brand team’s discretion.
· think you have an infection or have symptoms of an infection such as: fevers, sweats, or chills; muscle aches; cough; shortness of breath; blood in your phlegm; weight loss; warm, red, or painful skin or sores on your body; diarrhea or stomach pain; burning when you urinate or urinate more often than normal
After starting COSENTYX, call your doctor right away if you have any signs of infection listed above. Do not use COSENTYX if you have any signs of infection unless you are instructed to by your doctor. What are the possible side effects of COSENTYX?
COSENTYX may cause serious side effects, including: Serious allergic reactions
Serious allergic reactions can occur. Get emergency medical help right away if you get any of the following symptoms: feeling faint; swelling of your face, eyelids, lips, mouth, tongue, or throat; trouble breathing or throat tightness; chest tightness; skin rash or hives (red, itchy bumps).
If you have a severe allergic reaction, do not give another injection of COSENTYX.
Inflammatory bowel disease
New cases of inflammatory bowel disease or “flare-ups” can happen with COSENTYX, and can sometimes be serious. If you have inflammatory bowel disease (ulcerative colitis or Crohn’s disease), tell your doctor if you have worsening disease symptoms during treatment with COSENTYX or develop new symptoms of stomach pain or diarrhea. Severe skin reactions that look like eczema can happen during treatment with COSENTYX from days to months after your first dose and can sometimes lead to hospitalization. Your doctor may temporarily stop treatment with COSENTYX if you develop severe skin reactions. Tell your doctor if you have any of the following signs or symptoms: redness or rash; itching; small bumps or patches; your skin is dry or feels like leather; blisters on the hands or feet that ooze or become crusty or skin peeling.
The most common side effects of COSENTYX include: cold symptoms, diarrhea, and upper respiratory tract infections.
These are not all of the possible side effects of COSENTYX. Call your doctor for medical advice about side effects.
Before using COSENTYX, tell your doctor if you:
· have any of the conditions or symptoms listed above for infections.
· have inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
· are allergic to latex. The needle cap on the COSENTYX Sensoready® pen, and 150 mg/mL and 75 mg/0.5 mL prefilled syringes contains latex.
· have recently received or are scheduled to receive an immunization (vaccine). People who take COSENTYX should not receive live vaccines. Children should be brought up to date with all vaccines before starting COSENTYX.
· have any other medical conditions and all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.
· are pregnant or plan to become pregnant. It is not known if COSENTYX can harm your unborn baby. You and your doctor should decide if you will use COSENTYX.
· are breastfeeding or plan to breastfeed. It is not known if COSENTYX passes into your breast milk.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full Prescribing Information, including Medication Guide.
INDICATIONS
COSENTYX® (secukinumab) is a prescription medicine used to treat:
· people 6 years of age and older with moderate to severe plaque psoriasis (PsO) that involves large areas or many areas of the body, and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light alone or with systemic therapy)
· people 2 years of age and older with active psoriatic arthritis (PsA)
· adults with active ankylosing spondylitis (AS)
· adults with active non-radiographic axial spondyloarthritis (nr-axSpA) and objective signs of inflammation
· people 4 years of age and older with active enthesitis-related arthritis (ERA)
· adults with moderate to severe hidradenitis suppurativa (HS)
· fevers, sweats, or chills
· muscle aches
· cough
· shortness of breath
· blood in your phlegm
· weight loss
· warm, red, or painful skin or sores on your body
· diarrhea or stomach pain
· burning when you urinate or urinate more often than normal
Full cross-indication ISI that is visible upon scrolling
USE
Myfembree is used in premenopausal women ≥18 years of age to:
control heavy menstrual bleeding due to uterine fibroids or
manage moderate to severe pain associated with endometriosis
It should not be taken for more than 24 months.
Important Safety Information
Boxed Warning. Cardiovascular conditions: Myfembree may increase your chances of heart attack, stroke, or blood clots, especially if you are >35 years old and smoke or have uncontrolled high blood pressure. Stop taking Myfembree and call your healthcare provider (HCP) or go to the nearest emergency room right away if you have: leg pain or swelling that won’t go away; sudden shortness of breath; double vision, bulging of the eyes, sudden partial or complete blindness; pain or pressure in your chest, arm, or jaw; sudden, severe headache unlike your usual headaches; weakness or numbness in an arm or leg, or trouble speaking.
Do not take Myfembree if you:
have or have had blood clots in your legs, lungs, or eyes; a stroke or heart attack; a problem that makes your blood clot more than normal; blood circulation disorders; certain heart valve or rhythm problems that can cause blood clots to form in the heart; high blood pressure not well controlled by medicine; diabetes with kidney, eye, nerve, or blood vessel damage; certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision or migraine headaches if you are >35 years old; breast cancer or any cancer that is sensitive to female hormones; osteoporosis; undiagnosed vaginal bleeding; liver problems;
smoke and are >35 years old;
have had a serious allergic reaction (e.g., swelling of your face, lips, mouth or tongue, trouble breathing, skin rashes, redness) or swelling or an allergic reaction to relugolix, estradiol, norethindrone or any of the ingredients in Myfembree.
Bone loss (decreased bone mineral density [BMD]). While taking Myfembree, your estrogen levels may be low, which can lead to BMD loss. If this happens, your BMD may improve after you stop Myfembree, but complete recovery may not occur. It is unknown if these BMD changes could increase your risk for broken bones as you age. For this reason, you should not take Myfembree for more than 24 months. Your HCP may order an X-ray test called a DXA scan to check your BMD when you start Myfembree and periodically after you start if you have uterine fibroids or annually if you have pain associated with endometriosis.
Suicidal thoughts and behavior and worsening of mood. Call your HCP or get emergency medical help right away if you have any of these symptoms, especially if they are new, worse, or bother you: thoughts about suicide or dying, attempts to commit suicide, new or worse depression or anxiety, other unusual changes in behavior or mood. Pay attention to any changes, especially sudden changes in your mood, behaviors, thoughts, or feelings.
Abnormal liver tests. Call your HCP right away if you have any of these signs and symptoms of liver problems: jaundice, dark, amber-colored urine, feeling tired, nausea and vomiting, generalized swelling, right upper stomach area pain, bruising easily.
High blood pressure. See your HCP to check your blood pressure regularly.
Effects on pregnancy. Do not take Myfembree if you are trying to become or are pregnant. It may increase the risk of early pregnancy loss. If you think you are pregnant, stop taking Myfembree right away and call your HCP. Myfembree can cause decreased or no menstrual bleeding, making it hard to know if you are pregnant. Watch for other signs of pregnancy like breast tenderness, weight gain, and nausea. Myfembree does not prevent pregnancy. You will need to use effective non-hormonal methods of birth control (e.g., condoms, spermicide) during and for 1 week after stopping Myfembree. Do not take hormonal birth control such as birth control pills, because they may increase side effects and Myfembree may not work as well.
Uterine fibroid prolapse or expulsion. Fibroids can come out completely or partially through the vagina. Call your HCP right away if you have increased bleeding from the vagina, which can be serious, or cramping.
Severe allergic reactions. Myfembree may cause swelling of your face, lips, mouth or tongue, trouble breathing, skin rashes, and redness.
Most common side effects in heavy menstrual bleeding with uterine fibroids are hot flushes, increased sweating, night sweats, abnormal vaginal bleeding, hair loss or thinning, and decreased interest in sex.
Most common side effects in moderate to severe pain with endometriosis are headache, hot flushes/sweating/night sweats, mood changes including worsening depression, abnormal vaginal bleeding, nausea, toothache, back pain, decreased interest in sex, joint pain, tiredness, and dizziness.
These are not all the possible side effects of Myfembree. Call your doctor for medical advice about side effects.
Tell your HCP about all your prescription and over-the-counter medicines, vitamins, and herbal supplements. If you take oral P-gp inhibitors, take Myfembree first and wait at least 6 hours before taking the P-gp inhibitor. Ask your HCP if you are not sure if you are taking this type of medicine.
Tell your HCP if you are breastfeeding. Myfembree may pass into your breast milk.
Please see full Prescribing Information, including BOXED WARNING and Patient Information