Carnexiv

Carnevix is a prescription medication used to control certain types of seizures. Carnevix belongs to a group of drugs called anti-convulsant. These help to work by reducing abnormal electrical activity in the brain.

This medication is available as an injection and is administered into the vein by a healthcare provider. 

Common side effects include headache, injection site reactions and pain at the injection site. This medication can also cause tiredness, dizziness, and blurred vision. Do not drive or operate heavy machinery until this medication affects you. 

Carnexiv is a prescription medication used to treat adults with the following seizure types:

• partial seizures
• generalized tonic-clonic seizures (grand mal)
• mixed seizure patterns

This medication is given as a replacement therapy for oral carbamazepine when oral administration is not possible. 

Carnexiv is not indicated for the treatment of absence seizures (including atypical absence).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

The dose your doctor recommends may be based on the following:

• the condition being treated
• your oral carbamazepine dose
• other medications you are taking
• how you respond to this medication
• your kidney function

The maxiumum total daily dose for Carnexiv is 1120 mg, typically divided into 4 doses.

WARNING: SERIOUS DERMATOLOGIC REACTIONS and APLASTIC ANEMIA AND AGRANULOCYTOSIS

Serious Dermatologic Reactions and HLA-B*1502 Allele

Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have occurred in patients treated with carbamazepine. There is a strong association between the risk of developing SJS/TEN and the presence of HLA-B*1502, an inherited allelic variant of the HLA-B gene that is found almost exclusively in patients with Asian ancestry. Avoid use of CARNEXIV in patients testing positive for the allele unless the benefit clearly outweighs the risk. Discontinue CARNEXIV if you suspect that the patient is having a serious dermatologic reaction. 

Aplastic Anemia and Agranulocytosis

Aplastic anemia and agranulocytosis can occur during treatment with CARNEXIV. Obtain a complete blood count (CBC) before beginning treatment with CARNEXIV, and monitor CBC periodically. Consider discontinuing CARNEXIV if significant bone marrow depression develops.

Serious side effects have been reported with Carnexiv including the following:

• Life-threatening dermatologic reactions such as Stevens-Johnsons syndrome or toxic epidermal necrolysis. If you are of Asian descent, your doctor may order a genetic blood test to see if you are at a higher risk for these reactions. Seek emergency care immediately if you have some or all of the following symptoms of dermatologic reactions:
  • skin rash
  • hives
  • sores in your mouth
  • blistering or peeling of the skin
• Serious blood problems. Carnexiv may decrease the number of blood cells produced by your body enough to cause serious or life threatening health problems. Tell your healthcare provider right away if you have some or all of the following symptoms:
  • sore throat, fever, chills, or other signs of infection
  • easy bruising
  • bleeding gums or nose bleeds
  • feeling very tired
• Suicidal thoughts or actions. Tell your healthcare provider right away if you have some or all of the following symptoms, especially if they are new, worse, or worry you such as:
  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling agitated or restless
  • panic attacks
  • trouble sleeping
  • new or worse irritability
  • acting aggressive
  • being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking
  • other unusual changes in behavior or mood
• Life-threatening hypersensitivity that involves multiple organs in your body. Seek emergency care immediately if you have some or all of the following symptoms:
  • fever
  • rash
• Serious harm to your baby if you are pregnant. Carnexiv may cause serious congenital defects including spina bifida and cardiovascular malformation. Tell your doctor if you are pregnant.
• Serious risk of developing seizures and injuries. Talk to your doctor before discontinuing Carnexiv. Do not discontinue Carnexiv abruptly due to seizure risk and withdrawal signs and symptoms.
• Low level of sodium in your blood. Carnexiv may cause your body to retain more fluid than needed and decrease the concentration of serum sodium in your body. Tell your healthcare providers right away if you have some or all of the following symptoms such as
  • headache
  • confusion
  • muscle weakness
  • muscle cramps
  • restlessness 
  • feeling tired
  • vomiting 
• Liver problems. Tell your healthcare provider right away if you have some or all of the following symptoms:
  • yellowing if our skin or the whites of your eyes
  • dark urine
  • pain on the right side of your stomach area
  • easy bruising
  • loss of appetite
  • nausea or vomiting

Carnexiv can cause drowsiness, dizziness, and blurred vision. Do not drive or operate heavy machinery until you know how Carnexiv affects you.

Do not drink alcohol while taking Carnexiv. 

Do not take Carnexiv if you: 

• are allergic to Carnexiv or to any of its ingredients
• have bone marrow depression
• are allergic to any tricyclic antidepressants such as amitriptyline, imipramine and nortriptyline.
• are taking boceprevir
• have taken monoamine oxidase inhibitor within the last 14 days
• are taking nefazodone
• are taking delavirdine or other non-nucleoside reverse transcriptase inhibitor

Serious side effects have been reported with Carnexiv. See "Carnexiv Precautions."

Common side effects of Carnexiv include:

• headache
• injection site reactions
• pain at the injection site
• tiredness
• dizziness
• blurred vision

This is not a complete list of Carnexiv side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• CYP3A4 inhibitors such as aprepitant, cimetidine, ciprofloxacin, danazol, diltiazem, macrolide antibiotics (erythromycin, clarithromycin) fluoxetine, fluvoxamine, trazodone, olanzapine, loratadine, terfenadine, omeprazole, some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone.
• CYP3A4 inducers such as phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St John's wort
• CYP 1A2, 2B6, 2C9, 2C19, and 3A4 substrate such as aripiprazole, tacrolimus, temsirolimus, lapatinib, nefazodone, valproate. 

This is not a complete list of Carnexiv drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

Carnexiv may cause harm to your unborn baby. Your doctor will determine if the potential benefits outweigh the risks. 

If you become pregnant while taking Carnexiv, it is recommended to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This registry is collecting information regarding the effects of in utero exposure to this medication. 

If you do become pregnant, do Not stop taking your medication all of a sudden. 

If you are taking medication for seizures while pregnant, your doctor will more than likely recommend folic acid supplementation. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

Carnexiv has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Carnexiv, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.