Omadacycline (Intravenous)

Omadacycline injection is used to treat community acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

Omadacycline belongs to a group of medicines called tetracycline antibiotics. It works by killing bacteria or stopping them from growing. However, this medicine will not work for colds, flu, or other viral infections.

This medicine is given only by or under the direct supervision of your doctor.

It is very important for your doctor to check your progress closely to make sure this medicine is working properly. Blood and urine tests may be needed to look for unwanted effects.

Taking this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent getting pregnant. If you think you may have become pregnant while taking this medicine, tell your doctor right away.

This medicine may cause serious allergic reactions that can be life-threatening and need immediate medical help. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after taking this medicine.

Omadacycline may cause diarrhea, and in some cases, it can be severe. It may happen 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or last longer. If you have any questions about this or if mild diarrhea continues or gets worse, talk to your doctor.

This medicine may cause intracranial hypertension (increased pressure in the head). Tell your doctor right away if you have a headache, blurred vision, or any other change in vision.

Omadacycline injection may make your skin more sensitive to sunlight than usual. Being in the sun, even for short periods, may cause skin rash, itching, redness or other discoloration, or a severe sunburn. When you start taking this medicine:

• Stay out of direct sunlight, especially between 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Use a sunblock product with a sun protection factor (SPF) of at least 15. Some patients may need a product with a higher SPF, especially if they have a fair complexion. If you have any questions about this, ask your doctor.
• Use a sunblock lipstick with an SPF of at least 15 to protect your lips.
• Do not use a sun lamp or tanning bed or booth.

If you have a severe reaction to the sun, contact your doctor right away.

Do not take other medicines unless you have talked about them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your health care professional about any other types of allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Omadacycline injection may cause permanent discoloration of the teeth and slow down bone growth. This medicine should not be given to children younger than 8 years of age, unless directed by the child's doctor.

Geriatric

Appropriate studies performed to date have not shown any specific problems in elderly patients that would limit the usefulness of omadacycline injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Certain medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. In these situations, your doctor may need to change the dose or take other precautions. When receiving this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Acitretin

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Apixaban
• Ardeparin
• Argatroban
• Betrixaban
• Bexarotene
• Bivalirudin
• Certoparin
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Desirudin
• Edoxaban
• Enoxaparin
• Etretinate
• Fondaparinux
• Heparin
• Isotretinoin
• Lepirudin
• Magnesium Sulfate
• Methotrexate
• Palovarotene
• Parnaparin
• Phenindione
• Phenprocoumon
• Porfimer
• Protein C
• Reviparin
• Rivaroxaban
• Tinzaparin
• Tretinoin
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical conditions may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Diarrhea or
• Eye or vision problems—Use with caution. May make these conditions worse.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

Less common

• Blurred vision
• dizziness
• fainting
• fast, pounding, or irregular heartbeat or pulse
• fever
• headache
• hives, itching, skin rash
• hoarseness
• irritation
• itching of the vagina or genitals
• joint pain, stiffness, or swelling
• nervousness
• pale skin
• pounding in the ears
• redness of the skin
• sore mouth or tongue
• stomach pain
• swelling of the eyelids, face, lips, hands, or feet
• thick, white vaginal discharge with mild or no odor
• tightness in the chest
• troubled breathing or swallowing
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• white patches in the mouth or on the tongue

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

More common

• Chills
• dry, red, hot, or irritated skin
• nausea
• vomiting

Less common

• Belching
• change or loss in taste
• constipation
• diarrhea
• feeling of constant movement of self or surroundings
• heartburn
• increased sweating
• indigestion
• mouth or throat pain
• sensation of spinning
• stomach discomfort or upset
• trouble sleeping
• unusual drowsiness, dullness, or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Nuzyra

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antibacterial

Chemical Class: Tetracycline (class)

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. The medicine must be given slowly, so the needle will have to remain in place for at least 30 minutes.

• What are the strongest antibiotics available?
• What type of drug is Nuzyra (omadacycline)?