Valtoco

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Diazepam can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing. Your caregivers will watch you for symptoms such as weak or shallow breathing.

Tell your caregivers right away if you have:

• weak or shallow breathing;
• severe drowsiness;
• new or worsening seizures;
• unusual thoughts, hallucinations; or
• a light-headed feeling, like you might pass out.

The sedative effects of diazepam may last longer in older adults. Accidental falls are common in elderly patients who use benzodiazepines. Use caution to avoid falling or accidental injury shortly after receiving diazepam injection.

Common side effects may include:

• drowsiness;
• tired feeling;
• muscle weakness; or
• problems with balance or muscle movement.

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.

Read the entire detailed patient monograph for Valtoco (Diazepam Nasal Spray)

 

Valtoco Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

• Risk of Concomitant Use with Opioids [see WARNINGS AND PRECAUTIONS]
• Abuse, Misuse, and Addiction [see WARNINGS AND PRECAUTIONS]
• Dependence and Withdrawal Reactions After Use of VALTOCO More Frequently Than Recommended [see WARNINGS AND PRECAUTIONS]
• CNS depression [see WARNINGS AND PRECAUTIONS]
• Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS]
• Glaucoma [see WARNINGS AND PRECAUTIONS]
• Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice. The safety of VALTOCO is supported by clinical trials using diazepam rectal gel, as well as open-label, repeat-dose studies of VALTOCO in healthy subjects and epilepsy patients.

Diazepam Rectal Gel

In studies previously conducted with diazepam rectal gel, adverse event data were collected from double-blind, placebo-controlled studies and open-label studies. The majority of adverse events were mild to moderate in severity and transient in nature.

Two patients who received diazepam rectal gel died seven to 15 weeks following treatment; neither of these deaths was deemed related to diazepam rectal gel.

The most frequent adverse reactions (at least 4%) in the two double-blind, placebo-controlled studies were somnolence, headache, and diarrhea. Adverse events were usually mild or moderate in intensity.

Approximately 1.4% of the 573 patients who received diazepam rectal gel in clinical trials of epilepsy discontinued treatment because of an adverse event. The adverse reaction most frequently associated with discontinuation (occurring in three patients) was somnolence. Other adverse reactions most commonly associated with discontinuation and occurring in two patients were hypoventilation and rash. Adverse reactions associated with discontinuation occurring in one patient were asthenia, hyperkinesia, incoordination, vasodilatation, and urticaria.

In the two double-blind, placebo-controlled, parallel-group studies [see Clinical Studies], the proportion of patients who discontinued treatment because of adverse events was 2% for the group treated with diazepam rectal gel, versus 2% for the placebo group. In the diazepam rectal gel group, one patient discontinued because of rash and one patient discontinued because of lethargy.

Table 3: Adverse Reactions That Occurred in Greater Than 1% Of Patients in Parallel-Group, Placebo-Controlled Trials with Diazepam Rectal Gel and More Common Than Placebo

Adverse Reaction	Diazepam Rectal Gel N=101 %	Placebo N=104 %
Somnolence	23	8
Headache	5	4
Diarrhea	4	<1
Ataxia	3	<1
Dizziness	3	2
Euphoria	3	0
Incoordination	3	0
Rash	3	0
Asthma	2	0
Vasodilation	2	0

VALTOCO (Diazepam Nasal Spray)

Clinical studies of patients with epilepsy 6 years of age and older were conducted to support the safety and tolerability of VALTOCO for the treatment of acute repetitive seizures. A total of 190 patients 6 years of age and older received VALTOCO, of whom 114 received VALTOCO for at least 6 months, and 67 for at least 1 year. Other than adverse reactions related to local nasal administration, the adverse reactions reported in these studies were similar to those seen in the efficacy trials of diazepam rectal gel.

The most common local adverse reactions that occurred in VALTOCO-treated patients were nasal discomfort (6%), nasal congestion (3%), epistaxis (3%), and dysgeusia (2%).

Other Adverse Reactions

Diazepam rectal gel has previously been administered to 573 patients with epilepsy during all clinical trials, only some of which were placebo-controlled. All of the events listed below occurred in at least 1% of the 573 individuals exposed to diazepam rectal gel.

Body as a Whole: Asthenia

Cardiovascular: Hypotension, vasodilatation

Nervous: Agitation, confusion, convulsion, dysarthria, emotional lability, speech disorder, thinking abnormal, vertigo

Respiratory: Hiccup

The following infrequent adverse events have been reported previously with diazepam use: depression, slurred speech, syncope, changes in libido, urinary retention, bradycardia, cardiovascular collapse, nystagmus, urticaria, neutropenia, and jaundice.

Paradoxical reactions such as acute hyperexcited states, anxiety, hallucinations, increased muscle spasticity, insomnia, rage, sleep disturbances and stimulation have been reported with other diazepam products. If these events occur with the use of VALTOCO, the prescriber should consider discontinuation of use.

Read the entire FDA prescribing information for Valtoco (Diazepam Nasal Spray)

&Copy; Valtoco Patient Information is supplied by Cerner Multum, Inc. and Valtoco Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.