Indication
CAMBIA (diclofenac potassium for oral solution) is a
prescription medicine for migraine attacks in adults. It
does not prevent or lessen the number of migraines
you have, and it is not for other types of headaches.
Important Safety Information About Migraines
CAMBIA Prescription Migraine Relief
For Rapid Migraine Relief, Just Add Water.
Now you have a fast, effective option for the treatment of migraine, one designed to deliver rapid relief orally. Please take a moment to learn more about CAMBIA and what makes it different.
CAMBIA is a non-steroidal anti-inflammatory drug (NSAID) indicated for the acute treatment of migraine attacks with or without aura in adults 18 years of age or older.
CAMBIA is not indicated for prophylactic therapy or for cluster headache.
FAST
CAMBIA‘s powdered formulation is designed to act quickly to provide fast pain relief.
In one pivotal study, onset of the pain-relieving effect of CAMBIA was as fast as 15 minutes.
CAMBIA can be used at any time during a migraine attack.
In clinical studies, CAMBIA was taken by patients with moderate-to-severe headaches at the onset of symptoms.
EFFECTIVE
In clinical studies, CAMBIA has been proven to relieve the pain and associated symptoms of migraine, including nausea, sensitivity to light, and sensitivity to sound.
Proven pain-free response at 2 hours: 25.1% for CAMBIA vs 10.1% for placebo.
Health Care Providers: Click here for additional efficacy data.
SAFE
All prescription drugs may cause some side effects.
In clinical studies of CAMBIA, the majority of adverse events were mild-to-moderate and transient.
The most common treatment-attributable adverse event was nausea (3% for CAMBIA vs 2% for placebo).
See additional safety information, including boxed warning immediately below.
CAMBIA is a non-steroidal anti-inflammatory drug (NSAID). NSAIDs may increase your chance of a heart attack or stroke that can lead to death. This chance is higher with longer use of NSAID medicines and in people who have heart disease. CAMBIA should never be used right before or after certain heart surgeries.
NSAID medicines can also cause stomach and intestine problems, such as ulcers and bleeding, which can happen without warning and may cause death. This risk increases with use of steroids (corticosteroids), blood thinners (anticoagulants), smoking, alcohol use, older age, and for those in poor health.
CAMBIA should be used at the lowest dose possible and for the shortest time needed.
Tell your doctor if you:
- Are pregnant or may become pregnant, or are breast-feeding
- Have asthma, hives, or other allergic reactions with aspirin, diclofenac, other NSAIDs, or any medicines
- Suffer from “aspirin triad,” ie, aspirin allergy, nasal polyps, and asthma
- Have a history of stomach ulcers or bleeding in your stomach or intestines
- Have kidney or liver problems
- Have chest pain, shortness of breath, irregular heartbeats, fluid retention, high blood pressure, or have a headache different from your usual migraine
Also tell your health care provider about all the medicines you take, such as prescription and nonprescription medicines, including acetaminophen, diuretics, ACE inhibitors, thiazides, antibiotics, antiepileptics, aspirin, or any anticoagulant medicines (such as warfarin, Coumadin®, or Jantoven®). Also tell your health care provider about all the vitamins and herbal supplements you take. CAMBIA and other medicines may affect each other, causing side effects or altering the way each medicine works.
Possible serious side effects of CAMBIA include heart attack, stroke, high blood pressure, heart failure from body swelling (fluid retention), kidney problems including kidney failure, bleeding and ulcers in the stomach and intestines, low red blood cells (anemia), life-threatening skin reactions, life-threatening allergic reactions, liver problems including life-threatening liver failure, and asthma attacks in people who have asthma. Common side effects of CAMBIA include nausea and dizziness.
Get emergency help right away if you have any of the following symptoms of heart attack or stroke: shortness of breath or trouble breathing, chest pain, swelling of your face or throat, weakness in one part or one side of your body, or slurred speech. Stop CAMBIA and call your health care provider right away if you experience nausea that seems out of proportion to your migraine, stomach pain, sudden or severe pain in your belly; if you vomit blood; if you have blood in your bowel movement or it is black and sticky like tar; if you experience itching, skin rashes, or blisters with fever, yellow skin or eyes, swelling of your arms and legs or hands and feet, unusual weight gain, flu-like symptoms; if you are more tired or weaker than usual; or if you have any other side effects that bother you or do not go away.
These are not all the side effects with NSAID medicines. Talk to your health care provider for more information about NSAID medicines, and consult the Medication Guide and Prescribing Information for additional information about CAMBIA’s risks.
The health information provided here is not intended to replace discussions with a health care provider. Your health care provider weighs the risks and benefits based on your individual characteristics to determine whether CAMBIA is right for you.
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 and Patient Medication Guide for additional information, including safety information.