Khedezla

Khedezla is part of the drug class:

• Other antidepressants

Rare, but potentially life-threatening, conditions called serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions can happen when medicines such as Khedezla are taken with certain other medicines. Serotonin syndrome or NMS-like reactions can cause serious changes in how your brain, muscles and digestive system work. Especially tell your healthcare provider if you take the following:

• medicines to treat migraine headaches known as triptans
• medicines used to treat mood disorders, including tricyclics, lithium, selective serotonin reuptake inhibitors (SSRIs), or serotonin norepinephrine reuptake inhibitors (SNRIs)
• silbutramine
• tramadol
• St. John's Wort
• MAOIs (including linezolid, an antibiotic)
• tryptophan supplements

Ask your healthcare provider if you are not sure if you are taking any of these medicines. Do not take this medication with other medicines containing venlafaxine or desvenlafaxine.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Khedezla there are no specific foods that you must exclude from your diet when receiving this medication.

Desvenlafaxine is a selective serotonin and norepinephrine reuptake inhibitor (SNRIs) antidepressant. Desvenlafaxine affects chemicals in the brain that may be unbalanced in people with depression.

Desvenlafaxine is used to treat major depressive disorder.

Desvenlafaxine may also be used for purposes not listed in this medication guide.

Desvenlafaxine is used to treat depression. It belongs to a group of medicines known as serotonin and norepinephrine reuptake inhibitors (SNRIs). These medicines are thought to work by increasing the activity of chemicals called serotonin and norepinephrine in the brain.

This medicine is available only with your doctor's prescription.

This section provides information on the proper use of a number of products that contain desvenlafaxine. It may not be specific to Khedezla. Please read with care.

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may have to take desvenlafaxine for several weeks before you begin to feel better.

Take the tablet with or without food, and at the same time every day.

Swallow the extended-release tablet whole with water. Do not dissolve, crush, break, or chew it.

Part of the tablet may pass into your stools. This is normal and nothing to worry about.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (extended-release tablets):
  • For depression:
    • Adults—50 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• It is used to treat low mood (depression).
• It may be given to you for other reasons. Talk with the doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Khedezla affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Do not stop taking this medicine all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop Khedezla, you will want to slowly stop it as ordered by your doctor.
• High blood pressure has happened with this medicine. Have your blood pressure checked as you have been told by your doctor.
• Avoid drinking alcohol while taking Khedezla.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• This medicine may raise the chance of bleeding. Sometimes, bleeding can be life-threatening. Talk with the doctor.
• Some people may have a higher chance of eye problems with this medicine. Your doctor may want you to have an eye exam to see if you have a higher chance of these eye problems. Call your doctor right away if you have eye pain, change in eyesight, or swelling or redness in or around the eye.
• This medicine can cause low sodium levels. Very low sodium levels can be life-threatening, leading to seizures, passing out, trouble breathing, or death. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Khedezla.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Khedezla (desvenlafaxine) while you are pregnant.
• Taking this medicine in the third trimester of pregnancy may lead to some health problems in the newborn. Talk with the doctor.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Upset stomach or throwing up.
• Hard stools (constipation).
• Dry mouth.
• Change in sex ability.
• Not able to sleep.
• Feeling sleepy.
• Not hungry.
• Feeling tired or weak.
• You may see the tablet shell in your stool. This is normal and not a cause for concern.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Common side effects of Khedezla include: constipation, dizziness, drowsiness, insomnia, nausea, decreased appetite, hyperhidrosis, and xerostomia. Other side effects include: anxiety, blurred vision, mydriasis, tremor, vertigo, vomiting, abnormal dreams, chills, and yawning. See below for a comprehensive list of adverse effects.

Applies to desvenlafaxine: oral tablet extended release

Along with its needed effects, desvenlafaxine (the active ingredient contained in Khedezla) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking desvenlafaxine:

• Chills
• cold sweats
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, pounding, or irregular pulse
• headache
• numbness or tingling in the arms or legs
• shakiness in the legs, arms, hands, or feet
• trembling or shaking of the hands or feet
• trouble thinking, speaking, or walking
• weakness

• Blistering, peeling, or loose skin
• blood in the stool or urine
• chest tightness
• convulsions (seizures)
• cough
• diarrhea
• dilated or enlarged pupils (black part of the eye)
• feeling irritated
• fever
• hives, itching, or rash
• hoarseness
• joint pain, stiffness, or swelling
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of bladder control
• muscle pain
• muscle spasm or jerking of all extremities
• nosebleeds
• red skin lesions, often with a purple center
• red, irritated eyes
• red skin
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• sudden loss of consciousness
• swelling of the eyelids, face, lips, hands, or feet
• talking, feeling, or acting with excitement
• trouble breathing or swallowing
• unusual bruising
• unusual tiredness or weakness
• vomiting blood

Some side effects of desvenlafaxine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bigger, dilated, or enlarged pupils (black part of the eye)
• decreased appetite
• inability to have an orgasm
• inability to have or keep an erection
• increased sensitivity of the eyes to light
• loss of sexual ability, desire, drive, or performance
• sleepiness or unusual drowsiness
• sleeplessness

• Change in taste
• continuous ringing, buzzing, or other unexplained noise in the ears
• decreased weight
• difficult urination
• fear or nervousness
• hearing loss
• increased sensitivity of the eyes to light
• jitteriness
• lack or loss of strength
• loss of taste