Nuzyra (Intravenous)

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

Omadacycline is a type of tetracycline antibiotic. It kills bacteria or stops 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 that your doctor checks your progress closely to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

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

This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. 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 receiving this medicine.

Omadacycline may cause diarrhea, and in some cases, it can be severe. It may occur 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 make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with 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 other changes in vision.

Omadacycline injection may cause your skin to be more sensitive to sunlight than usual. Exposure to sunlight, even for short periods, may cause skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sunblock product that has a sun protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF, especially if they have a fair complexion. If you have any questions about this, check with your doctor.
• Apply a sunblock lipstick that has 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 from the sun, check with your doctor right away.

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

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. Consider the following for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies, 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 tooth discoloration and slow down bone growth. This medicine should not be given to children younger than 8 years old unless your child's doctor instructs you to do so.

Geriatric

Studies have not shown any specific problems in older adults that would limit the usefulness of omadacycline injection in this age group.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might happen. In these cases, your doctor might change the dose, or other precautions may be needed. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while receiving this medicine. The following interactions are based on their potential significance and are not a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or adjust 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 adjust the dose or frequency of one or both 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

Some medicines should not be used around mealtime or with certain foods due to potential interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Diarrhea or
• Eye or vision problems—Use with caution. This may worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may need medical attention.

Check with your doctor or nurse immediately 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. 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:

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.

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