Indication for Revonto (dantrolene sodium for injection)

Revonto is indicated, along with appropriate supportive measures, for the management of fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. It is also indicated preoperatively and sometimes postoperatively, to prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia in individuals judged to be malignant hyperthermia susceptible.

Important Safety Information for Revonto

The use of Revonto in the management of malignant hyperthermia crisis is not a substitute for previously known supportive measures. These measures must be individualized, but it will usually be necessary to discontinue the suspect triggering agents, attend to increased oxygen requirements, manage the metabolic acidosis, institute cooling when necessary, monitor urinary output, and monitor for electrolyte imbalance. Patients who receive i.v. dantrolene sodium preoperatively should have vital signs monitored.

If patients judged malignant hyperthermia susceptible are administered dantrolene sodium preoperatively, anesthetic preparation must still follow a standard malignant hyperthermia susceptible regimen, including the avoidance of known triggering agents. Monitoring for early clinical and metabolic signs of malignant hyperthermia is indicated because attenuation of malignant hyperthermia, rather than prevention, is possible.

Despite initial satisfactory response to i.v. dantrolene there have been reports of fatality, which involve patients who could not be weaned from dantrolene after initial treatment. The administration of i.v. dantrolene is associated with loss of grip strength and weakness in the legs, as well as drowsiness and dizziness. There have been reports of thrombophlebitis following administration of intravenous dantrolene. Tissue necrosis secondary to extravasation has been reported. Injection site reactions (pain, erythema, swelling), commonly due to extravasation, have been reported. Fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may occur with dantrolene sodium therapy.

For additional information visit www.revonto.com.

Click here for the Revonto full Prescribing Information

For More information on Malignant Hyperthermia please visit The Malignant Hyperthermia Association of the United States (MHAUS).


Indication for MYOBLOC (rimabotulinumtoxinB) injection

MYOBLOC is indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.

Important Safety Information for MYOBLOC

WARNING: DISTANT SPREAD OF TOXIN EFFECT

Postmarketing reports indicate that the effects of MYOBLOC and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses [see Warnings and Precautions].

MYOBLOC is contraindicated in patients with a known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.

MYOBLOC is contraindicated for use in patients with infection at the proposed injection site(s).

The potency Units of MYOBLOC are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of MYOBLOC cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method.

Treatment with MYOBLOC and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or swallowing. When distant effects occur, additional respiratory muscles may be involved.

Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months, and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised.

Treatment of cervical dystonia with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in a critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been postmarketing reports of serious breathing difficulties, including respiratory failure, in cervical dystonia patients. Patients treated with botulinum toxin may require immediate medical attention should they develop problems with swallowing, speech or respiratory disorders. These reactions can occur within hours to weeks after injection with botulinum toxin.

Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of MYOBLOC.

This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.

Only 9 subjects without a prior history of tolerating injections of type A botulinum toxin have been studied. Treatment of botulinum toxin naive patients should be initiated at lower doses of MYOBLOC.

Co-administration of MYOBLOC and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated.

The effect of administering different botulinum neurotoxin serotypes at the same time or within less than 4 months of each other is unknown. However, neuromuscular paralysis may be potentiated by co-administration or overlapping administration of different botulinum toxin serotypes.

It is not known whether MYOBLOC can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. MYOBLOC should be given to a pregnant woman only if clearly needed.

The most commonly reported adverse events associated with MYOBLOC treatment in all studies were dry mouth, dysphagia, dyspepsia, and injection site pain. Dry mouth and dysphagia were the adverse reactions most frequently resulting in discontinuation of treatment. There was an increased incidence of dysphagia with increased dose in the sternocleidomastoid muscle. The incidence of dry mouth showed some dose-related increase with doses injected into the splenius capitis, trapezius and sternocleidomastoid muscles.

To report SUSPECTED ADVERSE REACTIONS or product complaints, contact US WorldMeds at 1-888-461-2255, Option 2.
You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information, including Boxed WARNING and Medication Guide.


Indication for APOKYN (apomorphine hydrochloride injection)

APOKYN (apomorphine hydrochloride injection) is used by injection, as needed, to treat loss of control of body movements in people with advanced Parkinson's disease (PD). This condition is also called hypomobility or off episodes. An off episode may include symptoms such as muscle stiffness, slow movements, and difficulty starting movements. APOKYN may improve your ability to control your movements when it is used during an off episode. This may help you walk, talk, or move around easier. APOKYN is not used to prevent off episodes. APOKYN does not take the place of your other medicines for PD.

Important Safety Information for APOKYN

Do not take APOKYN if you are being treated with certain drugs called 5HT3 antagonists (including Anzemet®, Kytril®, Zofran®, Lotronex®, and Aloxi®) that are used for nausea and vomiting or irritable bowel syndrome. People taking these types of drugs with apomorphine experienced severely low blood pressure and lost consciousness or "blacked out."

Do not take APOKYN if you are allergic to APOKYN or its ingredients, notably sodium metabisulfite. Sulfites can cause severe, life-threatening allergic reactions in some people, especially in people with asthma.

Before taking APOKYN, tell your healthcare provider about all your medical conditions, including if you have dizziness, fainting spells, low blood pressure, asthma, liver problems, kidney problems, heart problems, a mental disorder called major psychotic disorder, have had a stroke or other brain problems, or drink alcohol.

Tell your healthcare provider about all medicines that you take because APOKYN may interact with other medicines causing serious side effects.

APOKYN must be injected just under the skin and not into a vein. Injecting APOKYN into a vein could cause a blood clot.

Your healthcare provider may prescribe a medicine called Tigan® (trimethobenzamide hydrochloride) to help prevent the severe nausea and vomiting that may occur when taking APOKYN. If Tigan is prescribed, your healthcare provider will determine how long you should remain on this medicine.

Some patients taking APOKYN may get sleepy during the day or fall asleep without warning doing everyday activities. Do not take medicines that make you sleepy while you are taking APOKYN. Until it is known how APOKYN affects your ability to stay alert, you should not drive a car or operate heavy machinery.

APOKYN may lower blood pressure and cause dizziness and fainting, especially when starting treatment or if the dose is increased. Alcohol, antihypertensives, and nitrates may increase this risk. Patients should not get up too fast from sitting or after lying down to minimize these problems.

The changes that occur with PD and the effects of some PD medicines can increase the risk of falling. APOKYN can also increase this risk.

APOKYN can cause or worsen psychotic-like behavior including hallucinations (seeing or hearing things that are not real), confusion, excessive suspicion, aggressive behavior, agitation, delusional beliefs (believing things that are not real), and disorganized thinking. Call your healthcare provider right away if you experience any of these symptoms.

Some people with PD may get sudden, uncontrolled movements after treatment with some PD medicines. APOKYN can cause or worsen this effect.

Some people with PD have reported new or increased gambling urges, increased sexual urges, and other intense urges, while taking PD medicines, including APOKYN. If you experience new or increased urges, tell your healthcare provider.

If you experience shortness of breath, fast heartbeat, chest pain, or if you have a change in your heartbeat, or faint while taking APOKYN, you should call your healthcare provider right away.

Some people with PD may have an increased chance of getting a skin cancer called melanoma. People with PD should have a healthcare provider check their skin for skin cancer regularly.

The most common side effects seen in clinical studies with APOKYN were: yawning; sleepiness; sudden uncontrolled movements; dizziness; runny nose; nausea and/or vomiting; seeing and hearing things that are not real; swelling of hands, arms, legs, and feet.

Some patients may notice soreness, redness, bruising, or itching at the injection site. Change the site with each injection.

Some people may develop depression while taking APOKYN. Call your healthcare provider right away if you become depressed with APOKYN.

Tell your healthcare provider if you are pregnant or plan to become pregnant or if you are breast-feeding or planning to breast-feed. It is not known if APOKYN can harm your unborn baby or if APOKYN passes into breast milk.

To report SUSPECTED ADVERSE REACTIONS or product complaints, contact US WorldMeds at 1-877-727-6596 (1-877-7APOKYN). You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Patients and care partners must receive complete instructions on the proper use of APOKYN. Please see full Prescribing Information and Pen Instructions for Use/ Patient Information.

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Indication for XADAGO (safinamide):

XADAGO (safinamide) is a type of prescription medicine known as monoamine oxidase type B (MAO-B) inhibitor used with levodopa and carbidopa to treat adults with Parkinson's disease (PD) who are having "off" episodes.

It is not known if XADAGO is effective to treat PD when taken as a single medicine (monotherapy).

Important Safety Information for Patients

Tell your physician if you are taking, or planning to take, any prescription or over-the-counter drugs.

Do not use XADAGO if you have hypersensitivity to safinamide, as this can cause swelling of the tongue and mouth and trouble breathing.

You should not take XADAGO if you have severe liver disease. Do not exceed a dose of 50 mg per day of XADAGO if you have moderate liver disease.

During treatment with XADAGO you may experience increases in blood pressure. Inform your physician if you have a history of high blood pressure. Possible symptoms of an unsafe rise in blood pressure include severe headache, blurred vision, confusion, seizures, shortness of breath, severe anxiety, and nausea and vomiting. Contact your doctor or seek immediate medical attention if you experience any of these symptoms.

Some patients treated with XADAGO experienced drowsiness or sudden onset of sleep. Do not drive, operate heavy machinery, work in high places or do other dangerous activities until you know how XADAGO affects you.

Restriction of foods and beverages containing tyramine is usually not required when treated with the recommended doses of XADAGO. However, it is recommended that you avoid foods containing high amounts of tyramine, such as aged cheeses, as some patients may have an increased sensitivity that could lead to an unsafe rise in blood pressure.

The most common side effects seen with XADAGO are uncontrolled movements (dyskinesia), falls, nausea, and insomnia.

To report SUSPECTED ADVERSE REACTIONS or product complaints, contact US WorldMeds at 1-888-492-3246 (1-888-4XADAGO). You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Prescribing Information and Patient Information.

For additional information, please visit www.xadago.com.