Marinol

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The following serious adverse reactions are described below and elsewhere in the labeling.

• Neuropsychiatric Adverse Reactions [see WARNINGS AND PRECAUTIONS]
• Hemodynamic Instability [see WARNINGS AND PRECAUTIONS]
• Seizures [see WARNINGS AND PRECAUTIONS]
• Paradoxical Nausea, Vomiting, and Abdominal Pain [see WARNINGS AND PRECAUTIONS]

Studies of AIDS-related weight loss included 157 patients receiving MARINOL at a dose of 2.5 mg twice daily and 67 receiving placebo. Studies of nausea and vomiting related to cancer chemotherapy included 317 patients receiving MARINOL and 68 receiving placebo. In the tables below is a summary of the adverse reactions in 474 patients exposed to MARINOL in studies.

Studies of different durations were combined by considering the first occurrence of events during the first 28 days.

A cannabinoid dose-related “high” (easy laughing, elation and heightened awareness) has been reported by patients receiving MARINOL in both the antiemetic (24%) and the lower dose appetite stimulant clinical trials (8%). The most frequently reported adverse experiences in patients with AIDS during placebo-controlled clinical trials involved the CNS and were reported by 33% of patients receiving MARINOL. About 25% of patients reported a CNS adverse reaction during the first 2 weeks and about 4% reported such a reaction each week for the next 6 weeks thereafter.

The following adverse reactions were reported in clinical trials at an incidence greater than 1%.

The following adverse reactions were reported in clinical trials at an incidence less than or equal to 1%.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of dronabinol capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

General disorders and administration site conditions: Fatigue

Hypersensitivity reactions: Lip swelling, hives, disseminated rash, oral lesions, skin burning, flushing, throat tightness [see CONTRAINDICATIONS]

Injury, poisoning and procedural complications: Fall [see Use In Specific Populations]

Nervous system disorders: Seizures [see WARNINGS AND PRECAUTIONS], disorientation, movement disorder, loss of consciousness

Psychiatric disorders: Delirium, insomnia, panic attack

Vascular disorders: Syncope [see WARNINGS AND PRECAUTIONS]

• AbbVie US LLC

Marinol capsules should be used with caution in patients with a history of seizure disorder because Marinol capsules may lower the seizure threshold.

Marinol capsules should be used with caution in patients with cardiac disorders because of occasional hypotension, possible hypertension, syncope, or tachycardia.

Marinol capsules should be used with caution in patients with a history of substance abuse, including alcohol abuse or dependence, because they may be more prone to abuse Marinol capsules as well. Multiple substance abuse is common and marijuana, which contains the same active compound, is a frequently abused substance.

Marinol capsules should be used with caution and careful psychiatric monitoring in patients with mania, depression, or schizophrenia because Marinol capsules may exacerbate these illnesses.

Marinol capsules should be used with caution in patients receiving concomitant therapy with sedatives, hypnotics or other psychoactive drugs because of the potential for additive or synergistic CNS effects.

Marinol capsules should be used with caution in elderly patients because they may be more sensitive to the neurological, psychoactive, and postural hypotensive effects of the drug.

Dronabinol may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have ever had depression or mental illness.

You should not use dronabinol capsules if you are allergic to sesame oil. You should not use dronabinol oral solution if you have had an allergic reaction to alcohol or if you also use disulfiram (Antabuse) or metronidazole (Flagyl).

Dronabinol can raise or lower blood pressure, especially in older adults or in people with heart problems.

Call your doctor at once if you have new or worsening mood symptoms, changes in behavior, headaches, vision problems, rapid heartbeats, or severe dizziness.

Get emergency medical help if you have signs of an allergic reaction: hives, skin rash or burning; mouth sores; warmth, redness, or tingly feeling; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a seizure;

• fast or pounding heartbeats;

• a light-headed feeling, like you might pass out;

• confusion, trouble sleeping, problems with memory or concentration;

• unusual changes in mood or behavior;

• restlessness, feeling nervous or irritable;

• slurred speech, drowsiness;

• severe or ongoing nausea, vomiting, or stomach pain; or

• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed.

Common side effects may include:

• feeling "high";

• dizziness, drowsiness, thinking problems;

• unusual thoughts or fears;

• feelings of extreme happiness; or

• nausea, vomiting, stomach pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Taking dronabinol with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking a sleeping pill, narcotic medication, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with dronabinol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Contraindications

Hypersensitivity to dronabinol, other cannabinoids, or any ingredient in the formulation (e.g., sesame oil).1

Warnings/Precautions

Warnings

Adverse CNS effects (e.g., a feeling of being “high,” somnolence) reported.1

General Precautions

Occasional hypotension, possible hypertension, syncope, or tachycardia may occur; use with caution in patients with cardiac disease.1

Seizures and seizure-like activity reported; may lower seizure threshold.1 Use with caution in patients with a history of seizure disorders1 and discontinue immediately if seizures occur.1

Marijuana, a frequently abused substance, contains the same active compound as dronabinol.1

Use dronabinol with caution in patients with history of substance abuse, including alcohol abuse or dependence.1

May exacerbate mania, depression, or schizophrenia; use with caution and careful psychiatric monitoring in patients with these disorders.1

Specific Populations

Category C.1

Distributed into milk.1 Avoid use in nursing women.1 23

Dronabinol and its pharmacokinetics have not been studied in pediatric patients; caution is advised if used in children for chemotherapy-induced nausea and vomiting because of psychoactive effects and lack of clinical experience.1 23

Use not recommended in pediatric patients with AIDS-related anorexia.1

Insufficient experience in patients ≥65 years of age to determine whether they respond differently than younger adults.1 Exercise caution; geriatric patients may be more sensitive to the drug’s neurologic, psychoactive, and postural hypotensive effects.1

Use with caution in geriatric patients with dementia; risk of falls may be exacerbated by adverse CNS effects (e.g., somnolence, dizziness).1 Initiate precautions to prevent falls before starting the drug and closely monitor patients during therapy.1

Common Adverse Effects

Adverse effects may be similar to those of marijuana (cannabis) and other cannabinoids (e.g., nabilone); adverse effects most commonly affect CNS.1 4 5 6 8 10 11 12 17

A cannabinoid, dose-related “high” (e.g., easy laughing, elation, euphoria, heightened awareness), asthenia, palpitations, tachycardia, vasodilation, facial flush, abdominal pain, nausea, vomiting, amnesia, anxiety, nervousness, ataxia, confusion, depersonalization, dizziness, hallucinations, paranoid reaction, somnolence, abnormal thinking.1 4 5 6 8 10 11 12 17

• It is used to help you eat more.
• It is used to treat upset stomach and throwing up.

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.
• Feeling sleepy.
• Feeling high (easy laughing and feeling good).

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.

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Neuropsychiatric Adverse Reactions[see Warnings and Precautions (5.1)]

• Advise patients that psychiatric adverse reactions may occur, especially in patients with a past psychiatric history or in those receiving other drugs also associated with psychiatric effects, and to report to their healthcare provider any new or worsening psychiatric symptoms.
• Advise patients, especially elderly patients, that cognitive impairment or an altered mental state may also occur during treatment with Marinol and to report to their healthcare provider if they develop signs or symptoms of cognitive impairment.
• Advise patients not to operate motor vehicles or other dangerous machinery until they are reasonably certain that Marinol does not affect them adversely. Alert patients to the potential for additive central nervous system depression if Marinol is used concomitantly with alcohol or other CNS depressants such as benzodiazepines and barbiturates.

Hemodynamic Instability

Advise patients, especially those with cardiac disorders, to report to their healthcare provider if they experience any signs or symptoms of hemodynamic instability, including hypotension, hypertension, syncope or tachycardia, especially after initiating or increasing the dosage of Marinol [see Warnings and Precautions (5.2)].

Seizures

Advise patients to discontinue Marinol and contact a healthcare provider immediately if they experience a seizure [see Warnings and Precautions (5.3)].

Multiple Substance Abuse

Inform patients with a history of substance abuse or dependence, including marijuana or alcohol, that they may be more likely to abuse Marinol. Advise patients to report to their healthcare provider if they develop abuse behaviors or conditions [see Warnings and Precautions (5.4)].

Paradoxical Nausea, Vomiting, or Abdominal Pain

Advise patients to report worsening nausea, vomiting or abdominal pain to their healthcare provider [see Warnings and Precautions (5.5)].

Pregnancy

Advise pregnant women of the potential risk to a fetus and to avoid use of Marinol during pregnancy [see Use in Specific Populations (8.1)].

Lactation

• Advise HIV infected women with anorexia associated with weight loss, not to breastfeed.
• Advise women with nausea and vomiting associated with cancer chemotherapy not to breastfeed during treatment with Marinol and for 9 days after the last dose [see Use in Specific Populations (8.2)].

Manufactured by:
Patheon Softgels Inc.
High Point, NC 27265

Manufactured for:
AbbVie Inc.
North Chicago, IL 60064, U.S.A.

1248A00 08/17 August, 2017

© 2017 AbbVie Inc.

This Patient Information has been approved by the U.S. Food and             Revised: August, 2017
Drug Administration.

1248A99 08/17

NDC 0051-0021-21

60 Capsules

2.5 mg CIII

Marinol® (dronabinol capsules, USP)

Each capsule contains: Dronabinol 2.5 mg

Rx only abbvie

NDC 0051-0022-21

60 Capsules

5 mg CIII

Marinol® (dronabinol capsules, USP)

Each capsule contains: Dronabinol 5 mg

Rx only abbvie

NDC 0051-0023-21

60 Capsules

10 mg CIII

Marinol® (dronabinol capsules, USP)

Each capsule contains: Dronabinol 10 mg

Rx only abbvie

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include changes in mood, memory problems, little or no urinating, constipation, loss of energy, problems with speech or coordination, or feeling light-headed.