Tag Archives: clinical trial labeling

FDA approves drug to treat Parkinson’s Disease

Sentry BioPharma Services provides drug product management, global drug distribution, GMP storage and specialized services like pharmaceutical labeling, packaging and kitting.  Sentry plays a critical role in protecting temperature-sensitive product safety, identity, strength, purity and quality (SISPQ) for both  clinical trials and commercial drug distribution for a wide range of pharmaceutical and biotechnology clients. 

The focus of our post this week is Parkinson’s Disease and treatment.  Therefore, we are sharing this article from the FDA concerning its new drug approval of Xadago.

The U.S. Food and Drug Administration today approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing “off” episodes. An “off” episode is a time when a patient’s medications are not working well, causing an increase in Parkinson’s symptoms, such as tremors and difficulty walking.

“Parkinson’s is a relentless disease without a cure,” said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “We are committed to helping make additional treatments for Parkinson’s disease available to patients.”

An estimated 50,000 Americans are diagnosed with Parkinson’s disease each year, according to the National Institutes of Health, and about one million Americans have the condition. The neurological disorder typically occurs in people over age 60, though it can occur earlier, when cells in the brain that produce a chemical called dopamine become impaired or die. Dopamine helps transmit signals between the areas of the brain that produce smooth, purposeful movement – such as eating, writing, and shaving. Early symptoms of the disease are subtle and occur gradually. In some people, Parkinson’s disease progresses more quickly than in others.

The efficacy of Xadago in treating Parkinson’s disease was shown in a clinical trial of 645 participants who were also taking levodopa and were experiencing “off” time. Those receiving Xadago experienced more beneficial “on” time, a time when Parkinson’s symptoms are reduced, without troublesome uncontrolled involuntary movement (dyskinesia), compared to those receiving a placebo. The increase in “on” time was accompanied by a reduction in “off” time and better scores on a measure of motor function assessed during “on” time than before treatment.

In another clinical trial of 549 participants, the participants adding Xadago to their levodopa treatment had more “on” time without troublesome uncontrolled involuntary movement compared to those taking a placebo, and also had better scores on a measure of motor function assessed during “on” time than before treatment.

Certain patients should not take Xadago. These include patients who have severe liver problems, or who take a medicine used to treat a cough or cold called dextromethorphan. It also should not be taken by patients who take another medicine called a monoamine oxidase inhibitor (MAOI) because it may cause a sudden severe increase in blood pressure, or by those who take an opioid drug, St. John’s wort, certain antidepressants (such as serotonin-norepinephrine reuptake inhibitors, tricyclics, tetracyclics, and triazolopyridines), or cyclobenzaprine, because it may cause a life-threatening reaction called serotonin syndrome.

The most common adverse reactions observed in patients taking Xadago were uncontrolled involuntary movement, falls, nausea, and trouble sleeping or falling asleep (insomnia).

Serious, but less common, risks include the following: exacerbated high blood pressure (hypertension); serotonin syndrome when used with MAOIs, antidepressants, or opioid drugs; falling asleep during activities of daily living; hallucinations and psychotic behavior; problems with impulse control/compulsive behaviors; withdrawal-emergent hyperpyrexia (fever) and confusion; and retinal pathology.

The FDA granted approval of Xadago to Newron Pharmaceuticals.

Sentry BioPharma Services offers temperature sensitive biological product management to pharmaceutical companies, hospitals and organizations with need for validated  GMP storage, labeling, kitting and temperature-sensitive drug distribution services.  For more information about how Sentry’s GMP services can help protect the integrity and delivery of your biological products to patients, contact Sentry via email or by phone at 1-866-757-7400.

Features & Benefits of Sentry’s Pharmaceutical Labeling & Packaging Services

Sentry BioPharma Services specializes in pharmaceutical and medical device packaging projects of varying scale, complexity and sensitivity to time and temperature. Sentry’s  full service light manufacturing through Food & Drug Administration (FDA) compliant pharmaceutical labeling and custom kitting functions provide clients the ability to store bulk products yet deliver kitted solutions to clinical sites and commercial customers across the global. This one-stop shop structure married with Sentry’s Foreign Trade Zone (FTZ) offers optimal flexibility and cost effective solutions to even the most intricate of drug development projects.

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Sentry Labeling and Packaging

Features of Sentry’s Pharmaceutical Labeling and Packaging Solutions 

GMP operation compliant with FDA regulations

o    FDA labeler code (3007066137)

o    Segregated labeling and packaging area

o    Total label operation accountability (line clearance)

 

Diverse Clinical Trial Labeling & Packaging Support

o    Open and blinded

o    Multi-lingual

o    Peel-off / Perforated

o    Serialized

 

Pharmaceutical & Medical Device Packaging

o    Bulk

o    Double-blind

o    Package inserts

o    Single / Multi-dose cartons

o    Tamper evident seals

On-Demand Services

o    Configurable stock management

o    Expiration management of individual kit components

o    Extend expiration

o    Pharmaceutical kitting

o    Reduce at-risk inventory

 

Adaptable Scheduling

o    Batch or lot specific

o    Batch size

 

Benefits of Sentry’s Pharmaceutical Labeling and Packaging Solutions 

Streamlined Production throughout Drug Development Phases – Avoid cumbersome logistics among vendors with Sentry’s full scope services from GMP pharmaceutical storage, biopharmaceutical labeling and packaging and extensive distribution.

Accurate Inventory Control from Bulk to Finish –  Sentry’s compliant, validated inventory management system and batch record process allow for accurate tracking of inventory levels during clinical trials and commercial launch.

Cost Effective Manufacture – Reduce pharmaceutical drug development costs with Sentry’s flexible storage, labeling and packaging offerings before, during and after FDA approval.

For more information about how a coordinated GMP storage, packaging and distribution model may reduce risk and strengthen the structure of your supply chain, contact Sentry via email or by phone at 1-866-757-7400.

Sentry’s New Vaccine Storage Campaign

Sentry BioPharma Services is proud to announce its new vaccine storage and distribution services campaign. Sentry’s decade long commitment to protect product integrity  married with its state-of-the-art facility provides the life sciences industry with a unique level of quality, regulatory and operational advantages that strengthen the vaccine supply chain. Sentry’s vaccine program advantages include:

Proven Track Record of Compliant Vaccine Storage, Rotation And Vaccine Drug Distribution

vaccinecampaignSentry’s long and unblemished regulatory inspection history is a reflection of its superior approach to standard operating procedures and temperature sensitive product management.

Large Scale Repository and Tracking Capabilities Through Advanced Inventory Management Systems

Live 24/7 real-time inventory tracking ensures full visibility of inventory throughout an organization and accurate tracking compliant with GMP storage regulations 21 CFR Parts 210 and 211. High-touch communication with the Sentry Operations and Quality Teams provides proper distribution of vaccines for routine fulfillment or pandemic response.

Advanced Building Management Systems That Monitor And Control Temperature Of Storage Environments

Sentry’s validated cold chain storage environments minimize time-out-of-refrigeration (TOR) risks, helping to reduce or eliminate waste attributable to deficient storage methods. The facility’s multi-tiered security structure and flexible storage options help fulfill requirements for specific seasonal or stockpile campaigns.

Trusted By Hospitals, Government Healthcare Agencies, And Manufacturers To Protect Vaccine Products And Stockpile

Over its ten years as a contract service organization, Sentry has been a trusted partner to hospitals, vaccine manufacturers and government healthcare organizations concerned with drug product integrity, vaccine storage security, risk management and timely vaccine distribution.

For more information about how Sentry’s temperature sensitive product management expertise can help you optimize your seasonal vaccine stockpile requirements, contact Sentry via email or by phone at 1-866-757-7400.

Sentry’s Controlled Substance Program Strengthens the Reliable and Secure Pharmaceutical Drug Supply Chain

Regulatory oversight shapes every dimension of controlled substances: licensing, registration, storage, security, use, inventory and controlled drug disposal. Finding a Drug Enforcement Administration (DEA) licensed partner to store, distribute and manage returns and destruction of Schedule III-V controlled substances while maintaining regulatory and quality standards required for a secure pharmaceutical supply chain can be a challenge. Sentry BioPharma Services provides seamless product management required to safeguard controlled substances which are brought into Sentry’s custody and care.

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Features & Benefits of Sentry’s Controlled Substance Program

DEA Regulation Secure Storage – Inspected and approved by the Drug Enforcement Administration  in 2014, Sentry’s state-of-the-art controlled substance capacity provides secure and reliable storage to support your pharmaceutical supply chain needs.

Controlled Substance Importation/Exportation – Sentry’s controlled substance importation and controlled substance exportation capabilities provide pharmaceutical organizations unique flexibility in the drug supply chain. This coupled with Sentry’s high quality standards affords pharmaceutical companies a competitive advantage throughout the drug development process.

Redundant Systems and Extensive Security Measures Product safety, identity, strength, purity and quality (SISPQ) remain intact.  Sentry features which support this agenda include:

  • Auxiliary power feeds and back-up systems
  • Continuous (24/7) security monitoring
  • Foreign Trade Zone (FTZ) status which allows controlled substances to be internationally shipped directly to Sentry where DEA, Customs & Border Patrol (CBP) and FDA clearances can be obtained within the security provided by Sentry’s GMP facility
  • Physical plant security
  • Redundant HVAC systems
  • Secure data and document programs

Pharmaceutical Labeling and Packaging – Sentry’s light pharmaceutical manufacturing capabilities help streamline clinical trial distribution and commercial drug distribution with one stop shop GMP labeling and GMP secondary packaging.

Drug Product Return and Drug Disposal Services – Sentry completes the controlled substance supply chain with a full-service approach to product guardianship.  Our drug product return and drug destruction program ensures project integrity, reliable inventory tracking and public safety from development to launch.

For more information about how Sentry can provide controlled substance supply chain solutions for your project, contact Sentry via email or by phone at 1-866-757-7400.

September is Charcot-Marie-Tooth (CMT) Awareness Month, Spread the Word!

CMT affects 1 in every 2,500 people worldwide, (a total of 2.8 million). That’s 1 too many.

What if each of those 2.8 million people ALL told five people about CMT?  Fourteen million new people would learn about CMT!  This is why the Charcot-Marie-Tooth Association (CMTA) declared September as CMT Awareness Month six years ago!

What is CMT? 

Charcot-Marie-Tooth Disease, or CMT, is a group of inherited disorders that affect the peripheral nerves, which are the nerves outside the brain and spinal cord. There are 90 kinds of CMT. Each kind is caused by a different kind of mutation, and more causes are being discovered every year.

CMT is just one kind of neuropathy (also called peripheral neuropathy), meaning simply that the peripheral nerves are damaged. There are many other causes of neuropathy, including the most common cause—diabetes.

CMT affects about 2.8 million people worldwide, of all races and ethnic groups.

Where Did the Name CMT Come From?

Charcot-Marie-Tooth is named after the three physicians who were the first to describe it in 1886: Jean-Martin Charcot, Pierre Marie and Howard Henry Tooth.

Charcot        Marie        Tooth

Inherited Disorders

CMT is inherited. It is not contagious, nor is it caused by anything in the environment. The most common forms of CMT are passed down from one generation to the next, meaning that it is dominantly inherited.

Some forms of CMT are recessively inherited—a person may be affected even though his or her parents do not have CMT. In this case, each of the parents harbors a mutation in one of their two copies of a CMT gene. If a child inherits one mutated CMT gene from each of their parents (the chance of this happening is one out of four), the child will develop CMT.

Sometimes the mutation that causes CMT happens spontaneously during the process that produces the eggs or sperm. In these rare cases, a child will have CMT even though neither parent has CMT. If a child has such a spontaneous mutation, he/she may pass that mutation down to his/her offspring.

Symptoms

Some types of CMT cause damage to the covering (myelin sheaths) that surrounds nerve fibers. Other kinds of CMT directly damage the nerves fibers themselves. In both cases, the damaged nerve fibers result in neuropathy. The nerves in the legs and arms, which are the longest, are affected first. Nerve fibers that create movement (called motor fibers) and nerve fibers that transmit sensations (called sensory fibers) are both affected. CMT causes weakness and numbness, usually starting in the feet.

In the most common kinds of CMT, symptoms usually begin before the age of 20 years. They may include:

  • Foot deformity (very high arched feet)
  • Foot drop (inability to hold foot horizontal)
  • “Slapping” gait (feet slap on the floor when walking because of foot drop)
  • Loss of muscle in the lower legs, leading to skinny calves
  • Numbness in the feet
  • Difficulty with balance
  • Later, similar symptoms also may appear in the arms and hands
  • CMT almost never affects brain function

foot

The foot of a person with CMT. The lack of muscle, a high arch, and claw toes are signs of this genetic disease. 

Diagnosis

A diagnosis of CMT is established through a thorough neurological evaluation by an expert in neuropathy, including a complete family history, physical exam, and nerve conduction tests, and appropriate genetic testing.

A physical exam may show:

  • Difficulty lifting up the foot while walking
  • Difficulty with dorsiflexion of the toes and ankles (upward movement, away from the ground) and other foot movements
  • Reduced or absent deep tendon reflexes (like the knee-jerk reflex)
  • Loss of muscle control and atrophy (shrinking of the muscles) in the feet and lower legs (and later the hands)

Genetic testing can provide the exact cause for most people who have CMT.

Prognosis (Expectations)

CMT usually gets worse, slowly, with age; rapid progression is rare, and should motivate a prompt re-evaluation. The problems with weakness, numbness, difficulty with balance, and orthopedic problems can progress to the point of causing disability. Pain can be an issue, either as a direct result of the neuropathy (neuropathic pain) or as consequence of orthopedic problems. Other potential complications include the following:

  • Progressive inability to walk from weakness, balance problems, and/or orthopedic problems
  • Progressive inability to use hands effectively
  • Injury to areas of the body that have decreased sensation

Treatments

There are no known treatments that will stop or slow down the progression of CMT, but the CMTA is funding research to find these treatments.

Physical therapy, occupational therapy, and physical activity may help maintain muscle strength and improve independent functioning.

Orthopedic equipment (such as braces, inserts, AFOs or orthopedic shoes) may make it easier to walk.

Orthopedic surgery on the feet can often maintain or even restore function to enable walking.

Clinical Trials

Although there is no cure for CMT, there are many clinical trials both completed and ongoing currently.  As many as 199 according to the website clinicaltrials.gov.

Participating in a clinical trial is an invaluable way to get involved in helping the research community cure CMT and related inherited neuropathies (INs). There are various types of clinical trials. Clinical trials are sometimes referred to as clinical studies or clinical research involving human volunteers that have been Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved, the regulatory agencies for the U.S. and Europe. These agencies require that a potential therapy be extensively tested in large groups of human volunteers before it can receive approval for commercialization.

Clinical trials are a vital part of the scientific research process and essential for developing therapies to prevent, treat, reverse and cure CMT. 

Strict adherence to clinical trial material management protocols, in combination with proven GMP storage, clinical trial labeling, secondary packaging and global drug distribution allows Sentry to provide clinical trial outsourcing clients with a variety of flexible services.

For more information about how Sentry BioPharma Services can integrate your requirements into a scalable, secure, value-added clinical trial logistics solution, contact Sentry via email or by phone at 1-866-757-7400.

For more information please visit the following websites:

http://www.cmtausa.org/

https://clinicaltrials.gov/

Features & Benefits of a Pharmaceutical Foreign Trade Zone

What is a Foreign Trade Zone?

The U.S. Foreign Trade Zone program was established by the Foreign Trade Zone Act of 1934 to “expedite and encourage foreign commerce” in the United States. Certain geographical areas, in or adjacent to Customs Ports of Entry, can obtain foreign-trade zone (FTZ) status and receive commercial merchandise under the same Customs standards as if it were outside the commerce of the United States. Any merchandise, including pharmaceutical products, admitted and held in a foreign trade zone can be exempt of any Customs duties, tariffs and other ad valorem taxes. No duty or back taxes are charged on “value-added,” or foreign-sourced parts or materials incorporated into a finished product using U.S. parts and labor until the product is officially imported into the U.S. Commerce. This tariff and tax relief lowers the costs of U.S.-based organizations engaged in international trade while creating and retaining employment and capital investment opportunities that result from those operations.

Benefits to the Biopharmaceutical Industryshutterstock_367703690

Pharmaceutical and biopharmaceutical companies can take advantage of Sentry’s GMP temperature-sensitive pharmaceutical storage and light manufacturing facility, which  resides in a foreign trade zone.  Sentry’s zone allows drug product to reside within the product’s designated temperature range, (such as API, biologics, controlled substances, etc.), while awaiting clearance for importation by the CBP and approved for distribution by the Food & Drug Administration (FDA).

During its stay in the FTZ, the biopharmaceutical  product can be further labeled and secondarily packaged  while greatly mitigating the numerous logistic and economic challenges encountered throughout the  drug importation and development process.

Logistic Benefits 

Unlimited Storage Terms Term of pharmaceutical material storage in an FTZ is indefinite.
Eliminated U.S. Quota Restrictions Product previously subject to quota limitations is now exempt from such restrictions.
Strengthened Foreign Pharmaceutical Supply Chain Eliminate administrative and importation hold-ups at Customs and ports of entry by bringing product straight to our GMP pharmaceutical storage environments ensuring product integrity: safety, identity, strength, purity and quality (SISPQ) along the drug supply chain.
Uninterrupted Local Manufacture Prior to Importation Product can be labelled, kitted and packaged and stored in the United States until need for importation into U.S. Commerce and Customs Clearance.
Expedited Release to Market Product can be held in an FTZ until FDA approval, greatly reducing time and logistic hassle from manufacturer to end-user.

Economic Benefits 

Duty Deferral or Duty Aversion  Import, admit and hold product without paying U.S. Customs duties.
Zero Inventory Taxes All materials held in an FTZ are exempt from state, county and local ad valorem taxes.
Country of Origin Marking and Labeling Country-of-origin labels are non-required on product admitted to an FTZ freeing companies from this expense.

Sentry BioPharma Services’ pharmaceutical supply chain management expertise and FTZ status across all storage environments ensures product integrity and project management flexibility.

For more information about how Sentry’s Foreign Trade Zone can help you optimize your medical and pharmaceutical import/export process, contact Sentry via email or by phone at 1-866-757-7400.

Read more about the Greater Indianapolis Foreign Trade Zone: inzone.org

Sentry BioPharma Services Offers Clinical Trial Support for Muscular Dystrophy

Sentry BioPharma Services serves pharmaceutical and biotechnology firms developing drugs for multiphase clinical trials for various indications.  One such indication is muscular dystrophy (MD).   According to the Muscular Dystrophy Association’s (MDA’s) website, “Muscular dystrophy, amyotrophic lateral sclerosis (ALS) and related muscle-debilitating diseases take away a person’s physical strength, independence and life.”

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Source: http://www.cdc.gov/ncbddd/musculardystrophy/freematerials.html

The National Institute of Neurological Disorders and Stroke (NINDS) indicates there is no specific prescription drug, biological product or vaccine to prevent, stop or reverse any form of MD. Treatment may include physical therapy, respiratory therapy, speech therapy, orthopedic appliances used for support, and corrective orthopedic surgery. Drug therapy includes corticosteroids to slow muscle degeneration, anticonvulsants to control seizures and some muscle activity, immunosuppressants to delay some damage to dying muscle cells, and antibiotics to fight respiratory infections.  Some individuals may benefit from occupational therapy and assistive technology.   Some patients may need assisted ventilation to treat respiratory muscle weakness and a pacemaker for cardiac abnormalities.

Some of the life-threatening diseases are as follows:

According to ClinicalTrial.gov, an on-line service provided to the public by the U.S. National Institutes of Health (NIH), there are approximately 125 open clinical studies in process currently.

Strict adherence to clinical trial material management protocols, in combination with proven GMP storage, clinical trial labeling, secondary packaging and global drug distribution allows Sentry to provide clinical trial outsourcing clients with a variety of flexible services.

For more information about how Sentry BioPharma Services can integrate your requirements into a scalable, secure, value-added clinical trial logistics solution, contact Sentry via email or by phone at 1-866-757-7400.

Clinical Trial of Chikungunya Vaccine

Safeguarding the health of clinical trial participants and the progression of trial results demands strict adherence to protocols.  Sentry BioPharma Services specializes in vaccine drug product storage, labeling, kitting and effective distribution for clinical trials worldwide.   Please see the following article concerning the National Institute of Health’s (NIH) phase 2 clinical trial of Chikungunya Vaccine which is now open and seeking patients.

NIH-Sponsored Clinical Trial of Chikungunya Vaccine Opens

This digitally-colorized transmission electron micrograph (TEM) depicts numerous chikungunya virus particles, which are composed of a central dense core that is surrounded by a viral envelope.
Credit: CDC
TEM

An experimental vaccine to protect against the mosquito-borne illness chikungunya is being tested in a Phase 2 trial sponsored by the National Institutes of Health. Results from an initial trial of the vaccine, which was developed by scientists at the NIH National Institute of Allergy and Infectious Diseases (NIAID), were reported in 2014. In that study, all 25 vaccine recipients developed robust immune responses and no safety concerns were noted. The new trial is designed to enroll 400 healthy adult volunteers aged 18 to 60 years old at six sites in the Caribbean. It will continue to gather data on the candidate vaccine’s safety and ability to elicit immune responses, including antibodies.
The hallmark symptoms of chikungunya are severe joint pain accompanied by fever and headache. The pain typically eases after about a week but can persist for months or years in some cases. There are no specific treatments for chikungunya infection and no vaccine to prevent it.
Since its appearance in the Western Hemisphere in late 2013, cases of chikungunya have skyrocketed. So far in 2015, more than 621,000 suspected and confirmed cases have been reported throughout the Americas.
“The recent re-emergence of chikungunya virus in this hemisphere has rapidly become a significant health burden,” said NIAID Director Anthony S. Fauci, M.D.  “Our chikungunya vaccine development efforts are part of a broader research effort to prevent, diagnose, treat and ultimately control this painful illness, which can strike anyone unlucky enough to be bitten by an infected mosquito.”
The experimental vaccine, developed by investigators at NIAID’s Vaccine Research Center, uses virus-like particles (VLPs) instead of either inactivated or weakened whole virus. VLP vaccines can stimulate immune responses comparable to those resulting from naturally acquired immunity following infection and, because virus is not needed to produce VLP vaccines, they do not need to be prepared in high-level biocontainment facilities.
Eligible volunteers will be randomly assigned to enroll into one of two groups of 200 people each. Study participants will receive either two doses of the candidate vaccine spaced 28 days apart or two doses of an inactive placebo. Blood samples will be drawn at multiple time points following the injections to assess whether the candidate vaccine prompted the production of antibodies to chikungunya virus.

Additional details about the trial can be found at ClinicalTrials.gov  using the identifier NCT02562482.

References:

L-J Chang et al. Chikungunya virus-like particle vaccine elicits neutralizing antibodies in healthy adults in a phase I dose escalation clinical trial. The Lancet DOI: 10.1016/S0140-6736(14)61185-5 (2014).

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Strict adherence to clinical material management protocols, in combination with proven GMP storage, secondary packaging, distribution, and shipping expertise allow Sentry to provide a variety of flexible services to our clinical trial outsourcing clients.

For more information about how Sentry can integrate your requirements into a scalable, secure, value-added clinical trial logistics solution, contact Sentry via email or by phone at 1-866-757-7400.

HPV (Human Papillomavirus) Vaccine – Gardasil®-9: What You Need to Know

Secure vaccine storage and distribution services protect your inventory throughout the supply chain. Sentry BioPharma Services ensures proper vaccine storage, rotation, accurate tracking and proper distribution of vaccines for routine fulfillment or pandemic response. Standard operating procedures (SOPs) and validated cold chain storage environments minimize time-out-of-refrigeration (TOR) risks, helping to reduce or eliminate waste attributable to inadequate storage methods.  Sentry provides the following vaccine information statement updated recently by the Centers For Disease Control and Prevention (CDC) concerning the human papillomavirus.

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HPV (Human Papillomavirus) Vaccine – Gardasil®-9: What You Need to Know

1. Why get vaccinated?

Gardasil-9 prevents human papillomavirus (HPV) types that cause many cancers, including:

  • cervical cancer in females,
  • vaginal and vulvar cancers in females,
  • anal cancer in females and males,
  • throat cancer in females and males, and
  • penile cancer in males.

In addition, Gardasil-9 prevents HPV types that cause genital warts in both females and males.

In the U.S., about 12,000 women get cervical cancer every year, and about 4,000 women die from it. Gardasil-9 can prevent most of these cases of cervical cancer.

Vaccination is not a substitute for cervical cancer screening. This vaccine does not protect against all HPV types that can cause cervical cancer.  Women should still get regular Pap tests.

HPV infection usually comes from sexual contact, and most people will become infected at some point in their life. About 14 million Americans, including teens, get infected every year.  Most infections will go away and not cause serious problems. But thousands of women and men get cancer and diseases from HPV.

2. HPV vaccine

Gardasil-9 is an FDA-approved HPV vaccine. It is recommended for both males and females. It is routinely given at 11 or 12 years of age, but it may be given beginning at age 9 years through age 26 years.

Three doses of Gardasil-9 are recommended with the second dose given 1-2 months after the first dose and the third dose given 6 months after the first dose.

3. Some people should not get this vaccine:

  • Anyone who has had a severe, life-threatening allergic reaction to a dose of HPV vaccine should not get another dose.
  • Anyone who has a severe (life threatening) allergy to any component of HPV vaccine should not get the vaccine.
  • Tell your doctor if you have any severe allergies that you know of, including a severe allergy to yeast.
  • HPV vaccine is not recommended for pregnant women. If you learn that you were pregnant when you were vaccinated, there is no reason to expect any problems for you or your baby. Any woman who learns she was pregnant when she got Gardasil-9 vaccine is encouraged to contact the manufacturer’s registry for HPV vaccination during pregnancy at 1-800-986-8999. Women who are breastfeeding may be vaccinated.
  • If you have a mild illness, such as a cold, you can probably get the vaccine today. If you are moderately or severely ill, you should probably wait until you recover. Your doctor can advise you.

4. Risks of a vaccine reaction

With any medicine, including vaccines, there is a chance of side effects. These are usually mild and go away on their own, but serious reactions are also possible.

Most people who get HPV vaccine do not have any serious problems with it.

Mild or moderate problems following Gardasil-9:

  • Reactions in the arm where the shot was given:
  • Soreness (about 9 people in 10)
  • Redness or swelling (about 1 person in 3)
  • Fever:
  • Mild (100°F) (about 1 person in 10)
  • Moderate (102°F) (about 1 person in 65)
  • Other problems:
  • Headache (about 1 person in 3)

Problems that could happen after any injected vaccine:

  • People sometimes faint after a medical procedure, including vaccination. Sitting or lying down for about 15 minutes can help prevent fainting, and injuries caused by a fall. Tell your doctor if you feel dizzy, or have vision changes or ringing in the ears.
  • Some people get severe pain in the shoulder and have difficulty moving the arm where a shot was given. This happens very rarely.
  • Any medication can cause a severe allergic reaction. Such reactions from a vaccine are very rare, estimated at about 1 in a million doses, and would happen within a few minutes to a few hours after the vaccination.

As with any medicine, there is a very remote chance of a vaccine causing a serious injury or death.

The safety of vaccines is always being monitored.  For more information, visit: www.cdc.gov/vaccinesafety/.

5. What if there is a serious reaction?

What should I look for?

Look for anything that concerns you, such as signs of a severe allergic reaction, very high fever, or unusual behavior.

Signs of a severe allergic reaction can include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness. These would usually start a few minutes to a few hours after the vaccination.

What should I do?

If you think it is a severe allergic reaction or other emergency that can’t wait, call 9-1-1 or get to the nearest hospital. Otherwise, call your doctor.

Afterward, the reaction should be reported to the “Vaccine Adverse Event Reporting System” (VAERS). Your doctor should file this report, or you can do it yourself through the VAERS web site at www.vaers.hhs.gov, or by calling 1-800-822-7967.  VAERS does not give medical advice.

6. The National Vaccine Injury Compensation Program

The National Vaccine Injury Compensation Program (VICP) is a federal program that was created to compensate people who may have been injured by certain vaccines.

Persons who believe they may have been injured by a vaccine can learn about the program and about filing a claim by calling 1-800-338-2382 or visiting the VICP website at www.hrsa.gov/vaccinecompensation. There is a time limit to file a claim for compensation.

7. How can I learn more?

  • Ask your health care provider. He or she can give you the vaccine package insert or suggest other sources of information.
  • Call your local or state health department.
  • Contact the Centers for Disease Control and Prevention (CDC):
  • Call 1-800-232-4636 (1-800-CDC-INFO) or

Visit CDC’s website at www.cdc.gov/hpv 

For more information about how Sentry’s proven vaccine management system can protect your vaccine throughout the global supply chain, contact Sentry via email or by phone at 1-866-757-7400.

 

Global Drug Supply Disruptions

Sentry BioPharma Services is a leading service provider for pharmaceutical companies needing to diversify their critical drug safety stocks, thereby reducing their risk of drug shortages brought on by unforeseen calamities.

“In the aftermath of the devastating earthquake and tsunami on March 11, 2011, our company entered into numerous agreements with Japanese pharmaceutical manufacturers,” stated Tim Mitchell, Sentry’s President.  “In support of their risk mitigation programs, companies divided their critical drug supplies between their facilities and Sentry’s central Indiana U.S. GMP facility”.

Earthquake

April 2016 Earthquake area: Traced from a report of The Geospatial Information Authority of Japan. 

The article below is provided for information purposes. 

Japan Today AFP

Plants shut down after quake, fueling economic fears

Apr. 16, 2016 – 06:10AM JST

TOKYO —

Some of Japan’s biggest firms including Sony and Toyota shut down operations in southern Japan Friday after the region’s deadly earthquake…

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Sentry provides GMP validated temperature product management and global distribution of high value drug products, from API to finished vaccines.  Sentry’s validated temperatures range from +15°C to -90°C with multiple temperature set points in between.

To learn more about how Sentry can help your company lower product loss risks contact Sentry via email or by phone at 1-866-757-7400.