Lunelle Monthly Contraceptive (Intramuscular)

Contraceptives are made to stop pregnancy. The combination of medroxyprogesterone and estradiol are two types of hormones that work by preventing a woman's egg from fully developing each month. The egg can no longer accept sperm, which stops fertilization. While contraceptives have other effects that help prevent pregnancy, this is the main way they work.

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

It is very important that your health care professional check your progress at regular visits to make sure this medicine does not cause unwanted effects. These physical exams will usually be every 12 months, but you need to visit your doctor every 28 to 30 days to get your injection.

This medicine does not protect a woman from sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS).

In deciding to use a medicine, you need to think about the risks of taking it compared to the benefits it will provide. This is a choice you will make with your doctor. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also tell your healthcare professional if you have other types of allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine can be used for birth control in teenage females and is not expected to cause different side effects or issues than it does in adults. Some teenagers may need more information about the importance of taking this medication exactly as prescribed.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction could happen. In those cases, your doctor may adjust the dose or take other precautions. When taking this medicine, it is crucial that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are highlighted for their potential significance and are not necessarily a complete list.

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

• Tranexamic Acid

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

• Abametapir
• Amifampridine
• Amoxicillin
• Ampicillin
• Amprenavir
• Apalutamide
• Aprepitant
• Armodafinil
• Artemether
• Bacampicillin
• Belzutifan
• Betamethasone
• Bexarotene
• Bosentan
• Bupropion
• Carbamazepine
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixime
• Cefpodoxime
• Cefprozil
• Ceftazidime
• Ceftibuten
• Cefuroxime
• Cenobamate
• Ceritinib
• Clobazam
• Cloxacillin
• Colesevelam
• Conivaptan
• Cyclacillin
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexamethasone
• Dicloxacillin
• Donepezil
• Doxycycline
• Efavirenz
• Elagolix
• Elvitegravir
• Encorafenib
• Enzalutamide
• Eslicarbazepine Acetate
• Etravirine
• Fedratinib
• Fexinidazole
• Fosamprenavir
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Griseofulvin
• Guar Gum
• Isotretinoin
• Itraconazole
• Ivosidenib
• Lesinurad
• Lixisenatide
• Lorlatinib
• Lumacaftor
• Mavacamten
• Meropenem
• Minocycline
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafcillin
• Nelfinavir
• Netupitant
• Nevirapine
• Octreotide
• Oxacillin
• Oxcarbazepine
• Oxytetracycline
• Penicillin G
• Penicillin G Procaine
• Penicillin V
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pitolisant
• Pixantrone
• Prednisolone
• Prednisone
• Primidone
• Red Clover
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Rufinamide
• Secobarbital
• Somatrogon-ghla
• St John's Wort
• Sugammadex
• Sultamicillin
• Tazemetostat
• Telaprevir
• Tetracycline
• Theophylline
• Ticarcillin
• Tigecycline
• Tirzepatide
• Topiramate
• Ulipristal
• Valproic Acid

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be necessary for your treatment. If both are prescribed, your doctor may adjust the dose or how often you use one or both of them.

• Atazanavir
• Diazepam
• Ginseng
• Lamotrigine
• Levothyroxine
• Licorice
• Lorazepam
• Selegiline
• Tacrine
• Temazepam
• Tipranavir
• Triazolam
• Troleandomycin
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or near mealtime, as interactions may occur. Using alcohol or tobacco with certain medicines can also cause interactions. The following interactions are highlighted for their potential significance and are not necessarily a complete list.

Using this medicine with any of the following may increase the risk of certain side effects but may be unavoidable in some situations. If used together, your doctor may adjust the dose or how often you use this medicine, or provide special instructions regarding food, alcohol, or tobacco use.

• Caffeine

Other Medical Problems

Having other medical problems may affect how this medicine works. Make sure to inform your doctor about any other medical issues, especially:

• Abnormal changes in menstrual or uterine bleeding
• Blood clots (or history of) or
• Gallbladder disease or gallstones (or history of) or
• Heart or circulation problems or
• High blood cholesterol or
• High blood pressure (hypertension) or
• Liver disease (or history of) or
• Mental problems—Combination contraceptives may worsen these conditions or, rarely, cause them to occur again.
• Cancer, including breast cancer— Contraceptives may worsen some cancers, especially if breast, cervical, or uterine cancers are present. Use of monthly injectable contraceptives is not recommended if you have any of these conditions. If you have a family history of breast disease, injectable contraceptives may still be a good option but you may need more frequent testing.

• Diabetes mellitus (sugar diabetes)—Use of combination contraceptives may cause a slight increase in your blood sugar and usually does not affect the amount of diabetes medicine you take.
• Migraine headaches—Combination contraceptives may cause fluid retention and may worsen these conditions; however, some individuals experience fewer migraine headaches when using contraceptives.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all side effects will occur, but if they do, they may require medical attention.

Contact your doctor right away if you experience any of the following side effects:

More common

• Bloating or swelling of the face, hands, lower legs, and/or feet
• Cough
• Difficulty swallowing
• Dizziness
• Fast heartbeat
• Hives
• Itching
• Loss of appetite and nausea
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Rapid weight gain
• Shortness of breath
• Tightness in the chest
• Unusual tiredness or weakness
• Vomiting blood
• Wheezing
• Yellowing of the eyes or skin

Symptoms of overdose—More common

• Nausea
• Menstrual irregularities
• Vaginal bleeding
• Vomiting

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

More common

• Abdominal pain or an enlarged abdomen
• Absent or missed menstrual periods
• Acne
• Allergic rash
• Brown, blotchy spots on the skin
• Decreased sex drive
• Depression
• Hair loss/thinning of hair
• Headache
• Increased menstrual bleeding or normal bleeding that starts earlier
• Lack or loss of strength

• Nervousness
• Quick to react or overreact emotionally
• Rapidly changing moods
• Stopping of menstrual bleeding for several months
• Vaginal yeast infection
• Weight change

In the U.S.

• Lunelle Monthly Contraceptive

Pharmacologic Class: Medroxyprogesterone

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 injection dosage form:For contraceptionAdults—0.5 milliliters (mL) injected into a muscle in the upper arm, upper thigh or in the buttocks every 28 to 30 days.

Missed Dose

Call your doctor or pharmacist for instructions.

If you miss having your next injection by day 33 your doctor will want to rule out pregnancy before the medicine is given to you again. Another method of birth control should be used until your period begins or until your doctor determines that you are not pregnant, and you are able to have the medicine again.