✅ Vivitrol 380 mg No. 1 bottle complete with solvent, syringe and needles

Vivitrol 380 mg No. 1 bottle complete with solvent, syringe and needles

Content

Indications Children and elderly patients Contraindications With caution Use during pregnancy and breastfeeding Side effects Interaction Method of administration and dosage Overdose Precautionary measures Storage conditions Expiration date

Indications

treatment of alcohol dependence in patients who are able to abstain from drinking alcohol before starting treatment (patients should not actively consume alcohol at the beginning of treatment with Vivitrol);
preventing relapse of opioid dependence after opioid detoxification (patients should not take opioids when starting treatment with the drug).

Treatment with Vivitrol should be part of an appropriate alcohol dependence program that includes psychosocial support.

Children and elderly patients

There are no data on the safety and effectiveness of the drug in children. Clinical trials of Vivitrol did not include enough patients over 65 years of age to compare the effect of treatment in older patients with younger patients.

Contraindications

patients taking narcotic analgesics;
when taking opioids during treatment with the drug;
patients in a state of acute opioid withdrawal (opioid withdrawal syndrome);
patients who fail a naloxone challenge or test positive for opioids in their urine;
patients with hypersensitivity to the active substance of the drug or any of its fillers and solvent components;
with severe liver dysfunction (including acute hepatitis and liver failure);
during pregnancy and lactation;
children under 18 years of age.

Carefully

Use for liver failure: patients with mild or moderately severe liver dysfunction (Child-Pugh classes A and B) do not require dose adjustment. The pharmacokinetics of Vivitrol have not been studied in patients with severe liver dysfunction. In such patients, Vivitrol, like all other IM injections, should be administered with caution due to the risks associated with IM injection (for example, in the presence of thrombocytopenia and coagulation disorders).

Use in renal failure: patients with mild renal failure (creatinine clearance 50–80 ml/min) do not require dose adjustment. The pharmacokinetics of Vivitrol have not been studied in patients with moderate to severe renal failure. Due to the fact that naltrexone and its primary metabolite are excreted primarily in the urine, it is recommended that Vivitrol be administered with caution to patients with moderate or severe renal impairment.

Use during pregnancy and breastfeeding

The effects of Vivitrol on pregnant women have not been studied. Vivitrol should be prescribed during pregnancy only if the potential benefit from its use outweighs the potential risk to the fetus.

Following oral administration of naltrexone, excretion of naltrexone and 6-β-naltrexol into breast milk has been noted. Due to the potential for carcinogenicity and the potential for serious adverse effects in nursing infants, a decision should be made to discontinue Vivitrol therapy during breastfeeding or discontinue breastfeeding during treatment, depending on the importance of therapy to the mother.

Side effects

Side effects in patients with alcohol dependence

Occurred in clinical trials in more than 5% of cases (frequent), the severity of these side effects was characterized as mild to moderate.

From the gastrointestinal tract: nausea, vomiting, diarrhea, frequent urge to defecate, gastrointestinal upset, frequent loose stools, abdominal pain, stomach discomfort, dry mouth, anorexia, decreased appetite, impaired appetite.
From the respiratory system: upper respiratory tract infections, laryngitis, sinusitis, pharyngitis (including streptococcal), nasopharyngitis.
General disorders and reactions at the injection site: pain, soreness, induration, swelling, itching, hemorrhage, asthenia, lethargy, lethargy.
Musculoskeletal system: arthritis, joint pain, joint stiffness, back pain, limb pain, muscle spasm, muscle twitching, muscle stiffness.
From the skin and subcutaneous tissues: rash, papular rashes, prickly heat.
From the nervous system: headache, migraine, dizziness, fainting, drowsiness, anxiety, sedation.

Side effects in patients with opioid dependence

They were basically the same as in patients with alcohol dependence.

The following are side effects in patients with opioid dependence that occurred in clinical trials in more than 2% of cases (common), the severity of these side effects was characterized as mild to moderate.

Laboratory indicators: increased activity of ALT, AST and GGT.
From the respiratory system: nasopharyngitis, influenza.
From the nervous system: insomnia, headache.
From the cardiovascular system: increased blood pressure.
General disorders and reactions at the injection site: pain.
From the gastrointestinal tract: toothache.

Side effects identified during pre-registration studies of the drug

From the gastrointestinal tract: taste perversion, increased appetite, reflux esophagitis, constipation, flatulence, hemorrhoids, colitis, gastrointestinal bleeding, paralytic ileus, pararectal abscess, gastroenteritis, tooth abscess, abdominal discomfort, acute pancreatitis.
General disorders and reactions at the injection site: fever, lethargy, chest pain, chest tightness, weight gain or loss, trembling, chills, facial swelling.
Mental disorders: irritability, sleep disturbance, alcohol withdrawal syndrome, agitation, euphoria, delirium.
From the nervous system: impaired attention, migraine, decreased mental activity, convulsions, ischemic stroke, cerebral artery aneurysms, paresthesia.
From the senses: blurred vision, conjunctivitis.
From the musculoskeletal system: pain in the limbs, muscle spasms, stiffness in the joints, myalgia.
From the skin and subcutaneous tissues: increased sweating, incl. at night, itching.
From the respiratory system: sore throat, shortness of breath, nasal congestion, obstructive bronchitis, bronchitis, pneumonia, laryngitis, sinusitis, upper respiratory tract infections.
Metabolic: heat stroke, dehydration, hypercholesterolemia.
From the cardiovascular system: hot flashes, deep vein thrombosis, pulmonary thrombosis, palpitations, atrial fibrillation, myocardial infarction, angina pectoris, unstable angina, chronic heart failure, atherosclerosis of the coronary arteries.
From the blood and lymphatic system: lymphadenopathy, incl. inflammation of the cervical lymph nodes, increased levels of leukocytes in the blood.
From the immune system: seasonal allergies, hypersensitivity reactions, incl. angioedema and urticaria, progression of HIV infection in HIV-infected patients.
From the genitourinary system: spontaneous abortion, decreased libido, urinary tract infections.
From the hepatobiliary system: cholelithiasis, increased activity of ALT and AST, acute cholecystitis.

Interaction

The interaction of Vivitrol with other drugs has not been studied.

Naltrexone is an antagonist of opioid-containing drugs (such as cough and cold medications, antidiarrheals and opioid analgesics).

Since naltrexone is not a substrate of cytochrome enzymes, inducers or inhibitors of these enzymes are unlikely to affect the clearance of Vivitrol. No studies have been conducted to assess the clinical significance of the effect of other drugs on the metabolism of Vivitrol, so caution should be exercised and the possible risks and potential benefits should be assessed when prescribing Vivitrol together with other drugs.

The safety indicators for using Vivitrol with and without antidepressants are the same.

Directions for use and doses

Intramuscularly, into the gluteal muscle, alternating buttocks.

Vivitrol should be administered by qualified healthcare professionals only using the ingredients provided in the package. Packaging components must not be replaced.

The recommended dose of Vivitrol is 380 mg IM once every 4 weeks or once a month.

Vivitrol cannot be administered intravenously!

If the patient misses the next dose, the next injection should be given as quickly as possible. Oral naltrexone is not required before using Vivitrol.

Resumption of treatment after a break. There are no data on resumption of treatment after a break.

Transferring patients with alcohol dependence from oral naltrexone to Vivitrol. There is no systematic data on the transfer of patients from oral naltrexone to Vivitrol.

Overdose

Data on overdose are very limited. Single doses of 784 mg were administered to 5 healthy volunteers. They reported no serious side effects.

Symptoms

: The most common side effects were injection site reactions, nausea, abdominal pain, drowsiness and dizziness. There was no significant increase in liver enzyme activity.

Treatment

: maintenance therapy.

Precautionary measures

To avoid the development of acute withdrawal syndrome in patients with opioid dependence and to prevent exacerbation of existing ones, patients should stop taking opioids at least 7-10 days before starting treatment with Vivitrol.

Since the absence of opioids in the urine is often insufficient to confirm the absence of opioids in the body, if there is a risk of withdrawal syndrome, a naloxone challenge test should be performed before using Vivitrol.

Elimination of blockade of opioid receptors with Vivitrol.

In an emergency situation in patients treated with Vivitrol, regional analgesia or non-narcotic analgesics are the preferred method of pain relief.

If patients require the use of narcotic analgesics for anesthesia or analgesia, such patients should be under long-term medical supervision.

Therapy with narcotic analgesics should be carried out by specially trained personnel (to avoid breathing problems) capable of performing mechanical ventilation in case of complications.

Regardless of the agent chosen to reverse the effects of naltrexone, the patient should be under constant supervision of qualified medical personnel in a specially equipped intensive care unit.

Depression and suicidal behavior.

Patients with alcohol and/or opioid dependence, incl. patients receiving treatment with Vivitrol. Family members and caregivers of patients should be advised to monitor closely for symptoms of depression or suicidal behavior and to immediately report such symptoms to their healthcare provider.

In patients with alcohol dependence. During controlled clinical trials of Vivitrol, suicidal behavior (suicidal ideation, suicide attempts, completed suicides) was observed infrequently, but occurred more often in the group of patients treated with Vivitrol than in the group of patients receiving placebo (1% vs. 0). In some cases, suicidal thoughts and behavior were recorded in the patient after completion of the study, but were a consequence of depression that developed during treatment with the drug. There were two suicides, in both cases the patients were treated with Vivitrol.

Discontinuation due to depression occurred more frequently in the Vivitrol group (1%) than in the placebo group (0).

In a 24-week placebo-controlled study, depression-related adverse events occurred in 10% of patients treated with Vivitrol 380 mg and in 5% of patients treated with placebo injections.

In patients with opioid dependence. During safety studies of Vivitrol, suicidal side effects (depressed mood, suicidal ideation, suicide attempts) were reported in 5% of opioid-dependent patients receiving Vivitrol and in 10% of patients receiving oral naltrexone.

In a 24-week placebo-controlled study, no adverse events such as depressed mood or suicidal ideation were observed in either the Vivitrol 380 mg group or the placebo injection group.

Reactions at the injection site.

Vivitrol injections may be accompanied by pain, tenderness, induration, swelling, erythema and itching. However, in some cases reactions at the injection site can be very severe. During clinical trials, one patient developed a lump that continued to enlarge 4 weeks after injection, followed by necrosis that required surgery to remove. During post-marketing surveillance, other cases of injection site reactions including induration, subcutaneous tissue inflammation, hematoma, abscess, sterile abscess and necrosis were observed, some of which required surgical intervention. In some cases, mostly in women, scarring has occurred at the injection site. Vivitrol is intended for injection into the gluteal muscle; accidental subcutaneous injection of the drug may increase the likelihood of serious adverse reactions at the injection site. The injection needle included in the package is designed specifically for administering Vivitrol and should under no circumstances be replaced with any other needle. In some cases, due to your body type, the length of the needle may not be sufficient for an intramuscular injection. Therefore, before giving an injection, the doctor must make sure that the needle is suitable for his patient. If the needle does not fit, another treatment should be prescribed. Patients should be warned about the need to inform their doctor about the occurrence of any reaction at the injection site. If signs of an abscess, inflammation of the subcutaneous tissue, necrosis or significant swelling occur, a decision should be made on the advisability of surgical intervention.

Alcohol withdrawal.

The use of the drug Vivitrol not only does not exclude, but also does not reduce the manifestation of symptoms associated with the withdrawal of alcohol intake.

Retinal artery occlusion.

Occlusion of the retinal artery after injection of another drug containing a copolymer of lactic and glycolic acid was very rare in post-registration studies and occurred in the presence of an abnormal arteriovenous anastomosis. During clinical and post-registration studies of Vivitrol, not a single case of retinal artery obstruction was observed. Vivitrol should be injected only into the gluteal muscle, avoiding entering a blood vessel.

Storage conditions

At 2–8 °C (do not freeze). Storage is allowed at a temperature not exceeding 25 °C for no more than 7 days. Avoid exposure to temperatures above 25 °C.

Keep out of the reach of children.

Best before date

3 years.

Do not use after the expiration date stated on the package.

Are there any dangers of Vivitrol treatment?

As a rule, Vivitrol implants are a safe treatment in most cases. However, risks may be present and complications may include complications at the site of Vivitrol implantation

Infection.
Inflammation - induration, swelling, erythema, bruising, necrosis.
Local allergic reaction - pain, redness, itching. tenderness, or itching.

Dangers of Vivitrol Treatment

Withdrawal symptoms: if alcohol metabolites are present in the body at the time of Vivitrol administration, the drug should absolutely not be used. Vivitrol blocks the effect of intoxication. Patients do not feel the effect of drinking alcohol. If they try to drink in small doses. However, it should be noted that drinking large doses of alcohol to try to bypass the blockade can lead to serious complications, coma or death. During treatment with Vivitrol, patients may not experience the expected effects of analgesics, antidiarrheals, or antitussives. Vivitrol may cause liver damage. Therefore, before starting treatment with Vivitrol, an examination is necessary. Patients should notify their doctor immediately if they develop symptoms and/or signs of liver disease. Treatment with Vivitrol can stimulate the formation of depression. If you experience the first signs of depression, you should immediately consult a doctor. Vivitrol can cause allergic pneumonia. Patients should notify their doctor immediately if they develop signs and symptoms of pneumonia, including shortness of breath, cough, or wheezing. Vivitrol has been shown to be most effective when used as an integrated therapy program that includes counseling and support.

Myths and facts about treatment for alcoholism

Only necessary in the most advanced cases

Fact: The statement is false.

In the later stages of alcoholism - not produced. Often this myth leads to the fact that people with advanced addiction decide to cure themselves of alcoholism. At this stage, the patient's condition is usually aggravated by many concomitant diseases, in which the administration of the drug may be risky. As a rule, in the later stages of the disease, the doctor individually selects a rehabilitation program.

Relieves alcoholism 100%

Fact: The statement is false.

This is only an auxiliary tool in situations where a person wants, but cannot, give up alcohol on his own. It is possible to convince an unmotivated person to get rid of alcoholism, but without further psychotherapeutic work on his motivation for sobriety, there will be no effect. On the Internet you can find a lot of advice and stories about how people conduct experiments on themselves in order to “overcome” the influence of the implanted drug, without having inner desire to lead a sober lifestyle.

The effect can only be in combination with intensive psychotherapy; it is an opportunity to “take a break”, learn to live sober, and form new habits for work and leisure.

Relieves cravings for alcohol

Fact: not true

Alcoholism treatment in itself does not in any way affect a person’s craving for alcohol. He cannot drink physically, but the desire to drink can persist for a very long time (even last for years until the drug wears off).

A severe reaction of the body when drinking alcohol can cause a negative attitude towards alcohol, but without psychotherapy, relieving dependence on alcohol using only “prohibitive” methods is almost impossible.

A reliable, stable effect after the end of the drug’s effect can be obtained only by combining stitching with a course of psychotherapeutic assistance. Only a course of psychotherapy will help relieve the patient of psychological and emotional dependence on alcohol and relieve the desire to drink.