A migraine is a condition that usually involves a certain type of headache with intense throbbing or pulsating, often on one side of your head. Migraines may also lead to other symptoms that bother you, such as nausea and sensitivity to light (photophobia) or sound (phonophobia). Symbravo is a combination medicine used to treat migraines with or without an aura. It contains meloxicam and rizatriptan. An aura can happen before or during a migraine. Auras can involve your vision (seeing flashing lights, zigzag lines, blind spots), hearing (ringing in your ears), or ability to speak. Auras can also involve muscle weakness or a tingling sensation.
How Does It Work?
Migraines are thought to happen because of chemical changes in your brain. Nerves send signals that change the levels of certain chemicals in your body, including serotonin and calcitonin gene-related peptide (CGRP). CGRP causes blood vessels around your brain to swell. Serotonin causes blood vessels to shrink. During a migraine, there seems to be an imbalance in these chemicals. This leads to inflammation and pain. Symbravo is a combination tablet that contains two medicines, meloxicam and rizatriptan. Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). There is an enzyme in your body called cyclooxygenase (COX-2). It helps your body to make chemicals that cause inflammation, fever, and pain. NSAIDs keep you from making cyclooxygenase. This helps to reduce migraine inflammation and pain. Rizatriptan is a triptan. Triptans act like serotonin. Serotonin helps to shrink blood vessels and acts on pain control pathways in the brain. Together, these two medicines in Symbravo can help treat migraines in more than one way.
How Was It Studied?
Symbravo has been studied in people with mild and moderate to severe migraines. The average age of people in the studies was about 41 to 42 years old, but ranged from 18 to 67 years old. Most of the people in the studies were White (about 80% across both studies; other races were not specified), and were female (about 84%). This is to be expected because migraines seem to be more common in females than in males. Only about 7% of people in the studies were using medicine to prevent their migraines.
These studies were done to see if Symbravo was safe to use and worked to reduce migraine pain and other bothersome migraine effects, including nausea, sensitivity to light (photophobia), and sensitivity to sound (phonophobia) two hours after taking the medicine. One study compared Symbravo to a tablet without any medicine in it (a placebo). In the other study, there were four groups being compared.
- Symbravo (meloxicam 20 mg/rizatriptan 10 mg)
- Meloxicam 20 mg
- Rizatriptan 10 mg
- A tablet without any medicine (a placebo)
What Are the Main Benefits?
Freedom from pain after two hours. Two hours after taking the medicine, the people who took Symbravo were more likely to report no pain, compared to those taking a placebo, for both mild migraine pain (32.6% for Symbravo versus 16.3% for the placebo) and moderate to severe migraine pain (19.9% for Symbravo versus 6.7% for the placebo).
Freedom from other bothersome migraine symptoms after two hours. The bothersome symptoms, other than pain, most often reported by people in the studies included sensitivity to light or photophobia (61%), nausea (20%), or sensitivity to sound or phonophobia (19%). Two hours after taking the medicine, the people who took Symbravo were more likely to report that their most bothersome symptom was gone, compared to those taking a placebo, for both mild migraines (43.9% for Symbravo versus 26.7% for the placebo) and moderate to severe migraines (36.9% for Symbravo versus 24.4% for the placebo). This seems to be mostly due to relief of photophobia and phonophobia, rather than nausea.
Still pain-free after 24 hours. The study with people with moderate to severe migraine pain also compared how many people were still pain-free after 24 hours without taking other medicine between Symbravo, meloxicam, and rizatriptan. More people who took Symbravo (16.1%) reported still being pain-free 24 hours after taking their medicine, compared to people who took either meloxicam (9%) or rizatriptan (11%).
Below is a summary of the significant results from these studies.
Study 1 (moderate to severe pain) | Study 2 (mild pain) | |||
Symbravo | Placebo | Symbravo | Placebo | |
| No pain after 2 hours | 19.9% | 6.7% | 32.6% | 16.3% |
| Most bothersome side effect gone after 2 hours | 36.9% | 24.4% | 43.9% | 26.7% |
| Still pain-free after 24 hours without taking other medicine | 16.1% | 5.3% | Result was not reported as significantly different | |
Are There Any Drug Interactions?
Several medicines can interact with Symbravo. Sometimes these interactions can be handled by separating medicines or changing doses. Sometimes these interactions are so important that the medicines should not be used at all if you are taking Symbravo, because using them together can be harmful. Below are some examples of medicines that can also be used for migraines that should not be used with Symbravo.
Propranolol (Inderal LA, Innopran XL) is a beta-blocker. It can be used for certain heart conditions, to lower blood pressure, or to prevent migraines. Propranolol can affect how your body handles rizatriptan (one of the ingredients in Symbravo). Taking both of these medicines can expose you to more rizatriptan than if you only took Symbravo. This might cause the levels to get too high and may increase your risk of side effects. You should not take Symbravo if you are taking propranolol or vice versa.
Ergots or ergot alkaloids are medicines that can be used to treat migraine headaches. Examples of ergots include dihydroergotamine (Migranal, Trudhesa, others) and ergotamine (Cafergot, Ergomar, Ergostat, others). Ergots and rizatriptan can both have effects on your blood vessels, causing a sudden narrowing. This can reduce blood flow and may increase your risk of serious side effects. Ergots and Symbravo should not be taken together.
Triptans are commonly used to treat migraines. Symbravo has a triptan in it, rizatriptan. Using more than one triptan together can increase the effects on your blood vessels, may reduce blood flow, and may increase your risk of serious side effects. You should not take Symbravo with any other triptan. Examples of available triptans include the following.
- Almotriptan (Axert)
- Eletriptan (Relpax)
- Frovatriptan (Frova)
- Naratriptan (Amerge)
- Rizatriptan (Maxalt)
- Sumatriptan (Imitrex and others)
- Zolmitriptan (Zomig)
This is not a complete list of interactions. Tell your pharmacist or doctor about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken.
What Can I Do to Prevent or Manage Certain Side Effects?
One of the most common side effects people report after taking Symbravo is dizziness. Dizziness can be described as feeling like the room is spinning or moving, when it really is not (which is called vertigo). Dizziness can also be described as feeling lightheaded, faint, unsteady on your feet, or woozy. If you feel dizzy, it is best to sit or lie down right away. This will lower your chance of falling down. If you have trouble with dizziness after taking Symbravo, let your health care provider know.
Another possible side effect with Symbravo is a rebound or medication overuse headache. A medication overuse headache happens when you use a medicine to treat your headaches more often than you should. Certain types of medicines are more likely to lead to medication overuse headaches than others. Taking nonsteroidal anti-inflammatory drugs or triptans too often can lead to medication overuse headaches. Symbravo has both of these types of medicines in it.
There are things you can do to reduce your risk of having medication overuse headaches. Follow your health care provider’s advice about how often you should take Symbravo. If you are having migraines more often than that, you can consider talking with your health care provider about using a medicine to prevent migraines. Know what your migraine triggers are and try to avoid them. Be sure to do the simple things like getting enough sleep, eating a healthy diet, getting regular exercise, and managing your stress. Together, all of these things may help to reduce your risk of a medication overuse headache.
Is There Any Cost Assistance Available?
Whether you’re eligible depends on your current medical and prescription coverage. There is a savings program that can help with out-of-pocket costs for commercially insured people. You may pay as little as $0 per month for Symbravo. Visit www.symbravo.com/savings-and-support/. If you have questions about costs, insurance, or any other questions about Symbravo, contact the drugmaker at 866-496-2976.
