Indication
Copaxone was approved by the U.S. Food and Drug Administration in 1996 for treating relapsing-remitting multiple sclerosis (RRMS). It’s a disease-modifying therapy, meaning it’s used to slow the progression of the disease rather than manage the symptoms of it.
RRMS is the most common form of MS, accounting for 85 percent of cases. Its symptoms come and go, rather than progressively getting worse.
Effectiveness
It’s not clear how Copaxone keeps MS relapses at bay. One theory is based on the fact that the drug’s chemical composition is similar to the myelin sheath that normally surrounds nerve cells. Myelin is the target of the immune system response in MS, which leads to its destruction. Copaxone seems to block T-cells from damaging the myelin, but the exact mechanism is not well known.
In addition, Copaxone is believed to reduce levels of B-cells, which may play a key role in MS. This is an area of ongoing research.
A paper published in 2019 reviewed MS advances and Copaxone’s continued use over a 20-year period. In looking at data acquired via magnetic resonance imaging (MRI), the researcher found data suggesting the drug reduces:
Axonal metabolic injuryTissue damageAtrophyBrain-volume loss
Other findings that were cited include:
Copaxone’s effectiveness is considered similar to that of interferon beta-1a and interferon beta-1b drugsResults of short-term studies are conflicting on whether brain-volume loss was improved more with Copaxone or interferon drugsA long-term study suggested brain-volume loss was reduced more by Copaxone than interferons
The paper’s author concluded that, in spite of its age, Copaxone is still widely used as a first-line treatment option, in part due to its effectiveness, the extensive data available, its safety profile, convenient dosing regimen (when compared to similar drugs), and the lack of a necessary monitoring program.
Administration
Copaxone comes in prefilled syringes and is given by injection using a short, slender needle that’s inserted subcutaneously into a two-inch pinch of skin. The most common injections sites are the abdomen, the back of an arm, the back of a hip, and the middle of a thigh.
This drug comes in two strengths: 20-milligram (mg) shots to be given daily and 40-milligram injections that are given three times a week.
Most people are able to give themselves their injections unless they’re injecting in a spot that’s difficult to reach. A Copaxone shot can sting, but only for a few minutes.
Side Effects
Many potential side effects may occur while taking Copaxone. It’s important to contact your healthcare provider right away about any side effects you may experience, particularly as the below lists—while extensive—are not exhaustive.
Common
More common side effects of taking Copaxone include:
AnxietyChest painCoughExcessive muscle toneRapid, pounding, or irregular heartbeatJoint painLower back or side painNeck painDifficult or pain urinationRedness of the face or upper bodyRashPuffiness in your faceSwollen, painful, or tender lymph glandsTrouble breathing
Injection-Site Reactions
Injection site reactions are common in people who take Copaxone for MS, leading to:
RednessSwellingItchingA lump at the injection site
A minority of Copaxone users—approximately 16 percent—experience a more dramatic adverse effect from Copaxone called an immediate post-injection reaction. This reaction happens right after an injection and may cause two or more of the following symptoms:
Flushing (skin warmth and/or redness)Chest painFast heart rateAnxietyShortness of breathThroat constrictionRash
Anyone can experience this reaction, which tends to occur several months after starting treatment with Copaxone. In some people, though, it can occur earlier. This reaction can occur more than once.
While they can be alarming, these symptoms don’t have any long-term consequences and typically go away after about 15 minutes. They also don’t require treatment.
Even so, the manufacturer of Copaxone advises you to call your healthcare provider right away if you experience a post-injection reaction and to not give yourself another injection until your healthcare provider tells you to resume this drug.
Less Common
Other less common side effects include:
Stay relaxedSit downKeep your head uprightBreathe slowlyHave someone with you during an injection, if possible
AgitationBloatingChillsConfusionDifficulty swallowingDizziness or lightheadednessFeverSevere, throbbing headacheGenital itchingMuscle achesPain during sexPurple spots or small lumps under the skinRapid weight gainRed streaks on your skinShaky, swollen, or tingling limbs, hands, or feetThroat spasmsStrong urge to urinateWhite, curd-like vaginal discharge (may have no or mild odor)Tightness of the chestUnusual weight changes
Though rare, the following are also possible:
Bloody urineBurning or stinging of the skinUncontrolled eye movementsSexual dysfunctionDiarrheaDifficulty movingEar painRapid breathingThrush (irritated mouth and tongue)Decreased appetiteMenstrual pain or changesPainful cold sores or blisters on the lips, nose, eyes, or genitalsSensation of movementSpeech problemsVision problems
Considerations and Contraindications
Copaxone is safe for most people. The only people who should never take it are those who are sensitive to glatiramer acetate or mannitol (a sugar alcohol).
There are no known interactions with other medications.
If you’re pregnant or breastfeeding, it’s probably safe to take Copaxone. It hasn’t been found to harm developing fetuses in animal studies or in reviews of data on more than 7,000 pregnancies.
Of all the MS disease-modifying drugs, Copaxone is generally considered the safest to use during breastfeeding. There are no published data, but any Copaxone in breastmilk is believed to be destroyed in the infant’s gastrointestinal tract rather than absorbed. One exception may be in newborns.
If you are pregnant, planning to become pregnant, or breastfeeding, be sure to discuss all medications with your healthcare provider.
Cost
Brand-name Copaxone costs between $6,000 to $7,500 a month or more, but generic forms that tend to be less pricey are on the market. Copaxone and its generic forms are covered by most medical insurance, as well.
